Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT03851861
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2019-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "A prospective intervention study in which participants with diagnosed Parkinson's disease are instructed to follow the Mediterranean diet for a 5-week intervention period."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroduodenal Permeability', 'timeFrame': 'Week 1; Week 5', 'description': 'The primary outcome is the change in gastroduodenal permeability induced by the Mediterranean diet. Gastroduodenal permeability will be assessed by measuring sucrose concentration in the 0 to 5-hour urine collection (end of intervention minus baseline)'}], 'secondaryOutcomes': [{'measure': 'Small Intestinal Permeability', 'timeFrame': 'Week 1; Week 5', 'description': 'The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)'}, {'measure': 'Colonic Permeability', 'timeFrame': 'Week 1; Week 5', 'description': 'The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)'}, {'measure': 'Whole Gut Permeability', 'timeFrame': 'Week 1; Week 5', 'description': 'The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)'}, {'measure': 'Stool Frequency', 'timeFrame': 'Week 1; Week 5', 'description': 'Difference in the average number of weekly stools (end of intervention compared to baseline)'}, {'measure': 'Stool Consistency', 'timeFrame': 'Week 1; Week 5', 'description': 'Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).'}, {'measure': 'Gastrointestinal Symptoms', 'timeFrame': 'Week 1; Week 5', 'description': 'Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 questions related to 5 syndromes, constipation, diarrhea, reflux, abdominal pain, and indigestion. Symptoms are scored 1=no discomfort to 7=very severe discomfort. Scores from each of the 15 questions are summed for the total GSRS score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intestinal Permeability', 'Mediterranean Diet', 'Leaky Gut', 'Intestinal Barrier Function'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '35002935', 'type': 'DERIVED', 'citation': "Rusch C, Beke M, Tucciarone L, Nieves C Jr, Ukhanova M, Tagliamonte MS, Mai V, Suh JH, Wang Y, Chiu S, Patel B, Ramirez-Zamora A, Langkamp-Henken B. Mediterranean Diet Adherence in People With Parkinson's Disease Reduces Constipation Symptoms and Changes Fecal Microbiota After a 5-Week Single-Arm Pilot Study. Front Neurol. 2021 Dec 23;12:794640. doi: 10.3389/fneur.2021.794640. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': "In this prospective, intervention study, participants with diagnosed Parkinson's disease will be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be assessed using food-grade sugar molecules. Participants will provide urine and stool samples to assess gut permeability and microbial communities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed Parkinson\'s disease aged 21-85 years\n* Hoehn \\& Yahr stage \\<3\n* Currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate\n* Willing and able to complete informed consent in English\n* Willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks\n* Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests.\n* Willing to provide urine and stool samples during the study collection periods.\n* Willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections.\n* Willing to maintain usual diet through the pre-baseline period\n* Willing to make dietary changes to follow a Mediterranean dietary pattern during the intervention period.\n* Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.\n* Willing to limit use of oral laxative medication to an "as-needed basis" (i.e. \\<3 times per week) during the full length of the study\n* Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on two occasions.\n* Willing to provide a social security number to receive study payment.\n\nExclusion Criteria:\n\n* Does not meet above criteria\n* Atypical or secondary Parkinsonism\n* History of deep brain stimulation\n* Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.\n* Daily use of anticholinergics or prokinetic agents\n* Use of enemas or suppositories to alleviate constipation\n* Use of another investigational product within 3 months of the screening visit.\n* Antibiotic use within 2 months from the day of stool collection\n* Good adherence to the Mediterranean diet during the pre-baseline period (score \\>6) based on the 14-item Mediterranean Diet Assessment Tool\n* Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn\'s disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or diverticular disease'}, 'identificationModule': {'nctId': 'NCT03851861', 'acronym': 'MED', 'briefTitle': "Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': "Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'IRB201900252'}, 'secondaryIdInfos': [{'id': 'OCR20178', 'type': 'OTHER', 'domain': 'UF OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet', 'description': 'Participants will be given individualized diet education on the Mediterranean diet and instructed to follow the diet for the 5-week intervention period. Individualized diet education will be administered by a licensed, registered dietitian nutritionist (RDN) followed by weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events.', 'interventionNames': ['Other: Mediterranean Diet']}], 'interventions': [{'name': 'Mediterranean Diet', 'type': 'OTHER', 'description': 'Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consumption of ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fresh fruits (including natural juices); d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish or seafood (at least one serving of fatty fish); f) ≥3 weekly serving of nuts or seeds; g) select white instead of red meats or processed meats (burgers, sausages); h) cook at least twice a week with a tomato herb sauce.\n\nParticipants will be instructed to eliminate or limit the consumption of the following foods: cream, butter, margarine, cold meat, paté, duck, carbonated and/or sugared beverages, pastries, industrial bakery products and desserts, French fries or potato chips, and out-of-home pre-cooked cakes and sweets. For usual drinkers, the main source of alcohol should be wine.', 'armGroupLabels': ['Mediterranean Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Bobbi Langkamp-Henken, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}