Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-02 @ 8:39 PM
Study NCT ID:
NCT04149418
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yogurt for Prevention of Chronic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015014', 'term': 'Yogurt'}, {'id': 'D064088', 'term': 'Hazard Analysis and Critical Control Points'}], 'ancestors': [{'id': 'D043302', 'term': 'Cultured Milk Products'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D059022', 'term': 'Food Safety'}, {'id': 'D063427', 'term': 'Food Quality'}, {'id': 'D005524', 'term': 'Food Technology'}, {'id': 'D019649', 'term': 'Food Industry'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D012449', 'term': 'Safety'}, {'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in systolic blood pressure', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in resting systolic blood pressure (change in control vs. change in yogurt)'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in resting diastolic blood pressure (change in control vs. change in yogurt)'}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Body mass index (change in control vs. change in yogurt)'}, {'measure': 'Change in Weight', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in body weight (change in control vs. change in yogurt)'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in waist circumference (change in control vs. change in yogurt)'}, {'measure': 'Compliance: Number of lids and Unused Containers', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Number of lids and unused containers of intervention foods (control vs. yogurt)'}, {'measure': 'Dietary records', 'timeFrame': '2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12', 'description': 'Comparison of dietary records (control vs. yogurt)'}, {'measure': 'Change in gut microbiota diversity', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in gut microbiota beta diversity (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal water ex vivo barrier disrupting activity', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in barrier disrupting activity of fecal water applied to cultured Caco-2 cells (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal total organic carbon', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in total organic carbon (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal butyrate', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal butyrate (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal propionate', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal propionate (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal acetate', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal acetate (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal bile acid (deoxycholic acid)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal deoxycholic acid (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal bile acid (lithocholic acid)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal lithocholic acid (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal bile acid (hyodeoxycholic acid)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal 3β,12α-Dihydroxy-5β-cholan-24-oic acid (change in control vs. change in yogurt)'}], 'primaryOutcomes': [{'measure': 'Change in Th17 proportion', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)'}], 'secondaryOutcomes': [{'measure': 'Change in Treg proportion', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Treg cells (change in control vs. change in yogurt)'}, {'measure': 'Change in Treg subpopulation', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt)'}, {'measure': 'Change in Th17 subpopulation (IL-17A+ TNFα+)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt)'}, {'measure': 'Change in Th17 subpopulation (IL-17A+ IFNδ+)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt)'}, {'measure': 'Change in Th17 subpopulation (IL-17A+ IL-22+)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt)'}, {'measure': 'Change in Th17 subpopulation (IL-17A+ FoxP3+)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt)'}, {'measure': 'Change in Th17 subpopulation (IL-17A+ IL-10+)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma tumor necrosis factor alpha (TNF-alpha)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma TNF-alpha (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interferon gamma (IFN-gamma)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IFN-gamma (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interleukin-6 (IL-6)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IL-6 (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interleukin-17A (IL-17A)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IL-17A (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interleukin-4', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IL-4 (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interleukin-22 (IL-22)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IL-22 (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma interleukin-10 (IL-10)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma IL-10 (change in control vs. change in yogurt)'}, {'measure': 'Change in plasma transforming growth factor beta (TGF-beta)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma TGF-beta (change in control vs. change in yogurt)'}, {'measure': 'Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt)'}, {'measure': 'Change in Forkhead box P3 (FoxP3) expression', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fasting FoxP3 expression (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal calprotectin', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal calprotectin (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal tumor necrosis factor alpha (TNF-alpha)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal TNF-alpha (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal interleukin 1 alpha (IL-1alpha)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal IL-1alpha (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal interleukin 1beta (IL-1beta)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal IL-1beta (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal interleukin-6 (IL-6)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal IL-6 (change in control vs. change in yogurt)'}, {'measure': 'Change in fecal interleukin-17A (IL-17A)', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Change in fecal IL-17A (change in control vs. change in yogurt)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['yogurt', 'obesity', 'intestine'], 'conditions': ['Obesity', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '39153426', 'type': 'DERIVED', 'citation': 'Hasegawa Y, Noll AL, Lang DJ, Akfaly EM, Liu Z, Bolling BW. Low-fat yogurt consumption maintains biomarkers of immune function relative to nondairy control food in women with elevated BMI: A randomized controlled crossover trial. Nutr Res. 2024 Sep;129:1-13. doi: 10.1016/j.nutres.2024.07.005. Epub 2024 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy premenopausal women age 21-55\n* BMI ≥ 25 kg/m2\n* not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)\n* resting blood pressure \\<140/90 mmHg\n* stable body weight for past two months\n* willing to maintain a normal exercise level (in general)\n* willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection\n* willing to avoid caffeine for 12 h before study visits\n* willing to fast 12 h prior to study visits\n* willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study\n\nExclusion Criteria:\n\n* self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)\n* have used oral antibiotics in the prior 21 days before sample collection\n* actively trying to lose weight\n* regularly taking anti-inflammatory drugs\n* vegetarian or allergic to soy or dairy\n* are pregnant, lactating, or trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT04149418', 'briefTitle': 'Yogurt for Prevention of Chronic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Anti-inflammatory Activity of Yogurt Mediated by the Intestine', 'orgStudyIdInfo': {'id': '2018-1262'}, 'secondaryIdInfos': [{'id': 'A074000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'AG&LSC/FOOD SCIENCE/FOOD SCIEN', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 1/10/2019', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yogurt-Control', 'description': 'Consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks, followed by a washout phase for 4 weeks, then consumption of 12 oz. control food (flavored soy pudding, 2 x 6 oz. servings) for 4 weeks.', 'interventionNames': ['Other: Yogurt', 'Other: Control food']}, {'type': 'EXPERIMENTAL', 'label': 'Control-Yogurt', 'description': 'Consumption of control food (flavored soy pudding, 2 x 6 oz. servings), followed by a washout phase for 4 weeks, then consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks.', 'interventionNames': ['Other: Yogurt', 'Other: Control food']}], 'interventions': [{'name': 'Yogurt', 'type': 'OTHER', 'description': 'Low-fat flavored yogurt', 'armGroupLabels': ['Control-Yogurt', 'Yogurt-Control']}, {'name': 'Control food', 'type': 'OTHER', 'description': 'Low-fat flavored soy pudding', 'armGroupLabels': ['Control-Yogurt', 'Yogurt-Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Department of Food Science, Babcock Hall', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Bradley W Bolling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Dairy Council', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}