Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06463769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Diet on the Microbiome-Immune-Brain Axis in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1: Patients with prodromal PD receiving nutritional intervention Arm 2: Patients with clinical PD receiving nutritional intervention Arm 3: Patients with clinical PD receiving standard of care (control)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'clinical motor symptoms', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'clinical examination'}, {'measure': 'clinical non-motor symptoms', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'clinical examination'}, {'measure': 'gastric emptying', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': '13C-breath test'}, {'measure': 'gastrointestinal transit time', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'using a test meal with food colouring and the time to colour appearance in stool'}, {'measure': 'gut motility', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'functional visceral MRI'}, {'measure': 'dietary adherence via serum markers', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'serum carotinoid and Trimethylamine oxid-levels will be combined and tertiles will be formed'}, {'measure': 'dietary adherence via healthy Nordic food Index', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'healthy Nordic food Index using data from a food frequency questionnaire'}, {'measure': 'food literacy effectiveness', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'self-perceived food literacy scale (questionnaire)'}, {'measure': 'patient acceptance', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': "Parkinson's Disease Questionnaire (PDQ-39)"}, {'measure': 'patient quality of life', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'Ways of Coping Questionnaire (WCQ)'}], 'primaryOutcomes': [{'measure': 'abundance of key SCFA-producing gut bacteria', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'analysis of stool samples'}], 'secondaryOutcomes': [{'measure': 'systemic inflammation markers', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'hsCRP and IL-6 in serum'}, {'measure': 'metabolic resilience', 'timeFrame': 'pre vs. post intervention (8 weeks)', 'description': 'modeling of one parameter (metabolic resilience) including information on postprandial glucose, insulin, triglycerides and NEFA following a mixed meal tolerance test'}, {'measure': 'gastrointestinal peptide-hormones', 'timeFrame': 'pre vs. post intervention (8 weeks)', 'description': 'ghrelin, GLP-1, PYY'}, {'measure': 'energy balance', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'changes in body weight'}, {'measure': 'energy partitioning', 'timeFrame': 'pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention', 'description': 'changes in body composition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['New Nordic Diet', "Parkinson's Disease", 'Microbiome-Immune-Brain axis'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '33557896', 'type': 'BACKGROUND', 'citation': "Aho VTE, Houser MC, Pereira PAB, Chang J, Rudi K, Paulin L, Hertzberg V, Auvinen P, Tansey MG, Scheperjans F. Relationships of gut microbiota, short-chain fatty acids, inflammation, and the gut barrier in Parkinson's disease. Mol Neurodegener. 2021 Feb 8;16(1):6. doi: 10.1186/s13024-021-00427-6."}, {'pmid': '35144237', 'type': 'BACKGROUND', 'citation': "Solch RJ, Aigbogun JO, Voyiadjis AG, Talkington GM, Darensbourg RM, O'Connell S, Pickett KM, Perez SR, Maraganore DM. Mediterranean diet adherence, gut microbiota, and Alzheimer's or Parkinson's disease risk: A systematic review. J Neurol Sci. 2022 Mar 15;434:120166. doi: 10.1016/j.jns.2022.120166. Epub 2022 Jan 26."}, {'pmid': '30306634', 'type': 'BACKGROUND', 'citation': "Maraki MI, Yannakoulia M, Stamelou M, Stefanis L, Xiromerisiou G, Kosmidis MH, Dardiotis E, Hadjigeorgiou GM, Sakka P, Anastasiou CA, Simopoulou E, Scarmeas N. Mediterranean diet adherence is related to reduced probability of prodromal Parkinson's disease. Mov Disord. 2019 Jan;34(1):48-57. doi: 10.1002/mds.27489. Epub 2018 Oct 10."}]}, 'descriptionModule': {'briefSummary': "Habitual adherence to a predominantly plant-based diet, rich in low-processed food (LPF) has been associated with a reduced risk for development and slower progression of Parkinson's Disease (PD). This could be due to neuroprotective effects by modulation of the gut microbiota and decreased neuronal and metabolic inflammation. So far, the effect of a predominantly plant-based LPF-diet on the microbiome-immune-brain axis in patients with PD remains unknown. In addition, the influence of dietetic measures on the gut microbiome is variable and may depend on (long-term) adherence as well as on PD-specific factors and lifestyle.\n\nThe investigators hypothesize that compared to an average German diet, the predominantly plant-based New Nordic LPF-diet, as a culturally adapted diet, which is rich in fermentable fiber and phytochemicals, will have beneficial effects on the gut microbiome of patients with PD by increasing the abundance of short-chain fatty acid (SCFA)-producing bacteria (primary outcome) and will improve gut motility, metabolic resilience, and inflammation (secondary outcomes). Furthermore, the investigators postulate that a patient-centered dietary intervention program, including a multifaceted patient education and supported by a web-application, will lead to high adherence as a key determinant of long-term changes in the gut microbiome. This dietary intervention will be accepted by patients as a low-threshold treatment that balances personal benefits, therapeutic barriers and ethical concerns of early risk disclosure in PD.", 'detailedDescription': 'In a pilot-intervention study, our project will:\n\n* develop a practical, low-threshold diet intervention for patients with prodromal and clinical PD. Adherence will be promoted (i) by a patient-oriented approach, (ii) by implementation of the predominantly plant-based New Nordic LPF-diet that is scientifically-based, culturally adapted, sustainable and culinary and (iii) by an innovative web-application.\n* investigate the acute effects of the predominantly plant-based New Nordic LPF -diet on the microbiome (abundance of SCFA-producing bacteria), gastrointestinal motility, inflammation as well as metabolic and Parkinson-specific clinical outcomes in individuals with prodromal and clinical PD.\n* investigate potential determinants of long-term changes in the gut microbiome (e.g. dietary adherence, gastrointestinal motility, meal timing and frequency), and factors associated with a high adherence (e.g. acceptance of diet as therapeutic intervention in the prodromal phase, health-related quality of life).\n\nThe patient-centered intervention program will be tailored to individual needs and preferences of individuals with prodromal and clinical PD. It will be designed to impart knowledge (e.g. on sustainability and health effects) and food literacy (e.g. food merchandize and culinary skills) in group meetings and culinary medicine workshops. Recipe suggestions and shopping guides will consider individual abilities and needs and a web-application is used for information, increasing self-efficacy, motivation, and monitoring. To ensure an easy integration of the diet into everyday life, partners will be included in the program, if applicable. Moreover, cultural preferences as well as financial resources will be considered. Regular feedback using statistics on nutrient intake and overall progress will be implemented to encourage adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with probable prodromal PD (according to predefined criteria)\n* patients with clinical PD with slight to moderate disease severity (Hoehn \\& Yahr 1-2.5)\n* habitual Western Diet (≥30% of energy intake from ultra-processed food)\n\nExclusion Criteria:\n\n* current adherence to a plant-based diet\n* food allergies or intolerances\n* significant diseases of the gastrointestinal system (e.g. celiac disease) or central nervous system, diabetes mellitus\n* underweight (BMI \\<18.5 kg/m2)\n* active smoking\n* expected changes in medication or antibiotic treatment during the intervention'}, 'identificationModule': {'nctId': 'NCT06463769', 'briefTitle': "Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': '"Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson\'s Disease" as Part of the Collaborative Research Center 1697 "Targeting the Microbiome-Immune-Brain Interaction in Neurodegeneration"', 'orgStudyIdInfo': {'id': 'CRC1697-C04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with prodromal PD on New Nordic LPF-diet (intervention)', 'description': 'Patients with prodromal PD will take part in an 8-week patient-centered intervention program on a predominantly plant-based New Nordic LPF-Diet.', 'interventionNames': ['Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program', 'Behavioral: maintenance of the predominantly plant-based New Nordic LPF-diet']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with clinical PD on New Nordic LPF-diet (intervention)', 'description': 'Patients with clinical PD will take part in an 8-week patient-centered intervention program on a predominantly plant-based New Nordic LPF-Diet. Patients with clinical PD will be randomized to intervention or control group.', 'interventionNames': ['Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program', 'Behavioral: maintenance of the predominantly plant-based New Nordic LPF-diet']}, {'type': 'NO_INTERVENTION', 'label': 'Patients with clinical PD receiving standard of care (control)', 'description': 'Patients with clinical PD will receive standard of care information on a healthy diet and serve as control. Patients with clinical PD will be randomized to intervention or control group.'}], 'interventions': [{'name': '8 week predominantly plant-based New Nordic LPF-diet program', 'type': 'BEHAVIORAL', 'description': 'An 8-week patient-centered dietary intervention program will be implemented to maintain a predominantly plant-based New Nordic LPF-Diet.', 'armGroupLabels': ['Patients with clinical PD on New Nordic LPF-diet (intervention)', 'Patients with prodromal PD on New Nordic LPF-diet (intervention)']}, {'name': 'maintenance of the predominantly plant-based New Nordic LPF-diet', 'type': 'BEHAVIORAL', 'description': 'Follow-up of long-term adherence to the diet at one and six months after completion of the intervention program.', 'armGroupLabels': ['Patients with clinical PD on New Nordic LPF-diet (intervention)', 'Patients with prodromal PD on New Nordic LPF-diet (intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Institute of Human Nutrition', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'contacts': [{'name': 'Eva Schäffer, MD', 'role': 'CONTACT', 'email': 'eva.schaeffer@uksh.de', 'phone': '+49431 500 23800'}], 'facility': 'Kiel University, University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'centralContacts': [{'name': 'Anja Bosy-Westphal, PhD, MD', 'role': 'CONTACT', 'email': 'abosyw@nutrition.uni-kiel.de', 'phone': '+494318805674'}, {'name': 'Eva Schäffer, MD', 'role': 'CONTACT', 'email': 'eva.schaeffer@uksh.de', 'phone': '+49431 500 23800'}], 'overallOfficials': [{'name': 'Anja Bosy-Westphal, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kiel University'}, {'name': 'Eva Schäffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kiel University, University Hospital Schleswig-Holstein'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Human Nutrition, Kiel University', 'investigatorFullName': 'Prof. Dr. Dr. Anja Bosy-Westphal', 'investigatorAffiliation': 'University of Kiel'}}}}