NCT04829760Completed
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Source: ClinicalTrials.gov · Last updated 20 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 31 Mar 2021
- Start date
- 13 May 2021
- Primary completion date
- 28 Apr 2024
- Lead sponsor
- University of Florida
- Diseases
- Parkinson disease
- NCT number
- NCT04829760
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 13 May 2021 to the primary completion date, 28 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently using a fiber supplement
- Use of another investigational product within 3 months of the screening visit
Other illness
- Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
Other
- Atypical or secondary Parkinsonism
- Underweight (BMI \<18.5)
- Inability to swallow study supplement due to swallowing concerns
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.