The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Const… (NCT04829760) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
United States35 participantsStarted 2021-05-13
Plain-language summary
This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physician-diagnosed Parkinson's disease
* Age 40-85 years
* Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
* Hoehn \& Yahr stage \< 4 in the clinical "ON" state
* Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
* Complete informed consent in English
* Maintain habitual diet and exercise routine throughout study period
* Consume the study intervention twice per day during the eight-week intervention period
* Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks
* Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit
Exclusion Criteria:
* Atypical or secondary Parkinsonism
* Underweight (BMI \<18.5)
* Inability to swallow study supplement due to swallowing concerns
* Currently using a fiber supplement
* Use of another investigational product within 3 months of the screening visit
* Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.