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NCT07914387

PHASE1

Stanford University Neurofiber Study

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

Parkinson's disease often causes constipation and changes in gut bacteria, but it is not known how quickly a daily fiber supplement changes gut physiology in people with Parkinson's, or how long any change lasts after stopping. This study will test how a daily fiber bar affects bowel function and gut inflammation in people with Parkinson's disease and in household members who live with them. Participants will eat one fiber bar (11 grams of fiber) each day for 3 months, then stop and be followed for one more month, for about 4 months in total. At three points (before starting, after 3 months of fiber, and one month after stopping), participants will collect a stool sample at home and mail it to Stanford in a provided kit, so no clinic visits are needed. Every week, participants will also fill out a short questionnaire about how often they have bowel movements, their bowel regimen, and they will complete a questionnaire about how bowel symptoms affect their daily life. In the lab, we will measure proteins in the stool that are signs of gut inflammation. We want to learn how fast these proteins change when fiber is added, whether changes last after fiber is stopped, and whether people with Parkinson's respond differently than their household partners. We expect that fiber will change gut inflammation and bowel function during the fiber period, and that these changes will differ between people with Parkinson's and their partners after the fiber bars are stopped. Results may help guide future research on diet and gut function in Parkinson's disease.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-01

Completion Date

2027-12-01

Last Updated

2026-11-03

Healthy Volunteers

Yes

Conditions

PARKINSON DISEASE (Disorder)

Interventions

DRUG

Prebiotic fiber bar

NeuroFiber® prebiotic fiber bar (Sorridi Therapeutics): a vegan, plant-based whole-food bar with a proprietary blend of 14 prebiotic and whole-food fibers, formulated as a source of prebiotic fiber to support short-chain fatty acid-producing gut bacteria. Each bar is one serving (50 g) with 11 g of fiber. Participants eat one bar daily and may choose one flavor (Lemon Cranberry or Dark Chocolate Cherry) or receive an equal shipment of both. Ingredients include a prebiotic fiber blend, date paste, almonds, walnuts, whole-grain oats, pumpkin and chia seeds, fruit, coconut, green tea extract, and vitamins D3, B12, and E; Lemon Cranberry also contains cashews and flax seeds, and Dark Chocolate Cherry also contains cocoa products. No inulin or gums. Contains tree nuts. Donated by the manufacturer. Tolerability previously assessed in open-label pilot NCT07127120.

Inclusion Criteria Arm 1: * Diagnosed with Parkinson's disease by a movement disorders specialist * Age 18+ * Lives with a participant in this study enrolled or planning to enroll in Arm 2 * Not currently consuming a fiber supplement Inclusion Criteria Arm 2: * No history of neurodegenerative disease, including Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Multiple Sclerosis * Age 18+ * Lives with a participant in this study enrolled or planning to enroll in Arm 1 * Not currently consuming a fiber supplement Exclusion Criteria Arm 1: * Allergy or intolerance to any ingredient in the study bar, including tree nuts, seeds, oats, coconut, or green tea extract * Difficulty swallowing (dysphagia) that makes eating a dense, solid food bar unsafe * History of bowel obstruction or major gastrointestinal surgery that makes a daily fiber supplement unsafe * Celiac disease, or severe kidney or liver disease, by participant report * Pregnant or lactating (breastfeeding), by participant report * History of inflammatory bowel disease (IBD) * Undergoing active treatment for cancer with chemotherapy or immunotherapy * Antibiotic use in the 2 weeks before baseline * Use of probiotic supplements in the 2 weeks before baseline * Consuming a fiber supplement * Diagnosis of or current concern for dementia Exclusion Criteria Arm 2: * Allergy or intolerance to any ingredient in the study bar, including tree nuts, seeds, oats, coconut, or green tea extract * Difficulty swallowing (dysphagia) that makes eating a dense, solid food bar unsafe * History of bowel obstruction or major gastrointestinal surgery that makes a daily fiber supplement unsafe * Celiac disease, or severe kidney or liver disease, by participant report * Pregnant or lactating (breastfeeding), by participant report * History of inflammatory bowel disease (IBD) * Undergoing active treatment for cancer with chemotherapy or immunotherapy * Antibiotic use in the 2 weeks before baseline * Use of probiotic supplements in the 2 weeks before baseline * Consuming a fiber supplement * History of neurodegenerative disease, including Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Multiple Sclerosis

Locations (1)

Stanford University Neurosciences

Stanford, California, United States