RightFit
Not yet recruitingPhase 1

Stanford University Neurofiber Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 4 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Analysis: Longitudinal changes in fecal inflammatory proteins and in questionnaire-based bowel measures will be compared across the three timepoints within participants and between PWP and cohabitating controls."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

CA