Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT03569020
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Diet Gout Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sjurasch@bidmc.harvard.edu', 'phone': '617-754-1416', 'title': 'Dr. Stephen Juraschek', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There may have been carryover effects from the interventions on the primary outcome (serum urate). We were not adequately powered to rule out carry over effects, using a period-by-intervention interaction term in our models.'}}, 'adverseEventsModule': {'timeFrame': 'This was a crossover design of 2 interventions. Each intervention lasted about 4 weeks. Adverse events in response to the intervention were assessed at the end of each intervention period during an in-person visit. Thus adverse event surveillance was performed at 4 weeks and 8 weeks for each participant in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Dietitian-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Self-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uric Acid Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.23', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '8.03', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Measured in serum', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a crossover design. All 43 participants underwent both interventions. The data is presented by first period assignment.'}, {'type': 'PRIMARY', 'title': 'Uric Acid Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.67', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '8.03', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4-weeks', 'description': 'Measured in serum', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a crossover study. Data are presented by first period assignment. The 4-week results represent period 1.'}, {'type': 'PRIMARY', 'title': 'Uric Acid Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.75', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8-weeks', 'description': 'Measured in serum', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a crossover design. Results are presented by period 1 assignment. The 8-week results represent the effect of the second period.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (mm Hg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '125.0', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '123.5', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Period 1 (4-weeks)', 'categories': [{'measurements': [{'value': '126.4', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '123.7', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 (8-weeks)', 'categories': [{'measurements': [{'value': '129.4', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '124.8', 'spread': '14.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure (mm Hg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74.9', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '72.6', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Period 1', 'categories': [{'measurements': [{'value': '76.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '77.3', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '74.0', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, 4-weeks, 8-weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '93.0', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '103.0', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': 'Period 1', 'categories': [{'measurements': [{'value': '96.5', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '103.2', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '97.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '16.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Measured in serum', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein Cholesterol (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '109.0', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '115.5', 'spread': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'Period 1', 'categories': [{'measurements': [{'value': '105.3', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '113.4', 'spread': '41.5', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '107.5', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '105.5', 'spread': '36.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Measured in serum', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'OG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.0', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Derived from baseline height, and serial weight measurements', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One person in the Dietitian-Directed Diet and then Self-Directed Diet did not provide a body mass index measurement during the follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'During the dietitian-directed diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.\n\nThis is followed by 4-weeks of the self-directed diet (referent diet).\n\nDuring the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.'}, {'id': 'FG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet.\n\nDuring the Dietitian-Directed Diet, participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dietitian-Directed Diet Then Self-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.\n\nSubsidy for food purchases and dietitian education: $105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.'}, {'id': 'BG001', 'title': 'Self-Directed Diet Then Dietitian-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "This was a crossover design. Baseline characteristics are presented by participants' period 1 assignment."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-29', 'size': 825000, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-22T07:41', 'hasProtocol': False}, {'date': '2019-06-10', 'size': 1273521, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-11T11:27', 'hasProtocol': True}, {'date': '2019-05-20', 'size': 814669, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-11T11:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators will not know which assignment the participants were given. The laboratory measuring uric acid will not know which intervention the participants were assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Half of participants will be randomly assigned 1 of 2 potential sequences. All participants will ultimately participate in each study period, but the order will be randomly assigned 1:1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-03', 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uric Acid Level', 'timeFrame': 'Baseline', 'description': 'Measured in serum'}, {'measure': 'Uric Acid Level', 'timeFrame': 'At 4-weeks', 'description': 'Measured in serum'}, {'measure': 'Uric Acid Level', 'timeFrame': 'At 8-weeks', 'description': 'Measured in serum'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure (mm Hg)', 'timeFrame': 'Baseline, 4-weeks, 8-weeks'}, {'measure': 'Diastolic Blood Pressure (mm Hg)', 'timeFrame': 'At baseline, 4-weeks, 8-weeks'}, {'measure': 'Fasting Blood Glucose (mg/dL)', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Measured in serum'}, {'measure': 'Low Density Lipoprotein Cholesterol (mg/dL)', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Measured in serum'}, {'measure': 'Body Mass Index (kg/m^2)', 'timeFrame': 'Baseline, 4-weeks, 8-weeks', 'description': 'Derived from baseline height, and serial weight measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'Nutrition', 'DASH', 'Gout', 'Hyperuricemia', 'Potassium', 'Uric acid', 'Trial', 'Blood pressure', 'Glucose', 'Lipid', 'Cholesterol', 'Weight', 'Arthritis', 'BMI', 'Body mass index', 'Fruit', 'Vegetable', 'Low fat dairy', 'Lean meat', 'Fiber'], 'conditions': ['Gout', 'Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '33186448', 'type': 'DERIVED', 'citation': 'Ghazi L, Drawz PE, Pajewski NM, Juraschek SP. The Association of Orthostatic Hypotension With Ambulatory Blood Pressure Phenotypes in SPRINT. Am J Hypertens. 2021 May 22;34(5):511-520. doi: 10.1093/ajh/hpaa184.'}, {'pmid': '32933342', 'type': 'DERIVED', 'citation': 'Miller HN, Charleston J, Wu B, Gleason K, White K, Dennison Himmelfarb CR, Ford DE, Plante TB, Gelber AC, Appel LJ, Miller ER 3rd, Juraschek SP. Use of electronic recruitment methods in a clinical trial of adults with gout. Clin Trials. 2021 Feb;18(1):92-103. doi: 10.1177/1740774520956969. Epub 2020 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'Unhealthy diet has long been associated with high uric acid levels and gout. The DASH diet may lower uric acid levels. This study will examine the effects of the DASH diet on uric acid in adults with a history of gout.', 'detailedDescription': 'The public health burden of gout is substantial. Several lines of evidence suggest that a DASH diet might lower uric acid. However, there are no trials of the DASH diet in adults with gout. This trial is a cross-over study of the effects of a DASH-like diet on uric acid in adults with gout and hyperuricemia, who are not taking urate-lowering therapy.\n\nPerpetuated by the "Western" lifestyle and resulting obesity epidemic, the prevalence of gout has increased over the past few decades to 3.9% of US adults (8.3 million individuals). This prevalence increases with age to 9.3% of US adults over 60 years (4.7 million).\n\nParticipants will be community-dwelling adults, aged 18+ with a baseline serum uric acid level of 7 mg/dL, who have a self-reported history of gout and are not taking urate lowering medications (e.g. allopurinol, febuxostat, probenecid).\n\nThis trial is comprised of two study periods: (1) a dietitian-directed diet (DD) or (2) self-directed usual diet (SD). Each period lasts 4 weeks. All participants will participate in both periods, but half will undergo the dietitian-directed diet first while the other half will undergo the self-directed diet first. During the dietitian-directed diet, participants will receive $105/week of foods in a pattern that conforms to the DASH diet. The DASH diet emphasizes fruit, vegetables, lean meat, low fat dairy, and high fiber, while restricting red meat, sweets, and sugary beverages. During the self-directed diet, participants will be asked to eat their typical diet outside of the study. Investigators anticipate 40 participants in this study.\n\nThe primary outcome is uric acid. Secondary outcomes of this study include: body mass index, systolic and diastolic blood pressure, fasting cholesterol, and fasting blood glucose. Both primary and secondary outcomes will be measured 3 times: (1) before the study begins (baseline), (2) after period 1 (at 4 weeks), and (3) after period 2 (at 8 weeks). Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed throughout the study as well.\n\nThe primary comparison will be serum uric acid concentrations measured after the 4-week dietitian-directed diet versus uric acid concentrations measured after the 4-week self-directed diet (DD vs. SD). Comparisons will be made within person using generalized estimating equations (GEE) with and without adjustment for baseline uric acid concentration. Investigators will use GEE models for secondary outcomes as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18-100 years\n\nSelf-reported gout diagnosis\n\nSerum Uric Acid \\> 7 mg/dL\n\nExclusion Criteria:\n\nRecent or planned changes to urate lowering therapies (e.g. allopurinol, febuxostat, probenecid)\n\nRecent or planned changes to hypertension, lipid, or diabetes medications\n\nPatients with hyperkalemia (\\>5 mmol/L)\n\nChronic kidney disease (GFR \\< 30 cc/min), kidney transplant, dialysis\n\nGastro-intestinal conditions (e.g. history of gastric bypass surgery, active inflammatory bowel disease, malabsorption, or major GI resection)\n\nActive cancer treatment (e.g. radiation or chemotherapy)\n\nDiagnosis of any of the following in the past 6 months: heart attack, heart failure, angina, coronary bypass or angioplasty, or Chronic Obstructive Pulmonary Disease (COPD)\n\nAlcohol use over 14 drinks per week\n\nInability to give informed consent\n\nActive use of warfarin, insulin, or chronic steroids (like prednisone)\n\nTerminal or mental illness'}, 'identificationModule': {'nctId': 'NCT03569020', 'acronym': 'DIGO', 'briefTitle': 'The Diet Gout Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout', 'orgStudyIdInfo': {'id': 'IRB00153409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietitian-Directed Diet', 'description': 'Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.', 'interventionNames': ['Other: Subsidy for food purchases and dietitian education']}, {'type': 'NO_INTERVENTION', 'label': 'Self-Directed Diet', 'description': 'Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.'}], 'interventions': [{'name': 'Subsidy for food purchases and dietitian education', 'type': 'OTHER', 'description': '$105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.', 'armGroupLabels': ['Dietitian-Directed Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21207', 'city': 'Woodlawn', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins ProHealth Research Clinic', 'geoPoint': {'lat': 39.32288, 'lon': -76.72803}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Edgar Miller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Rheumatology Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}