Status:
COMPLETED
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Lead Sponsor:
University of Florida
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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 bow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04829760
Start Date
May 13 2021
End Date
April 28 2024
Last Update
June 20 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611