The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
- Conditions
- Parkinson Disease
- Interventions
- Dietary Supplement: Coarse wheat branDietary Supplement: MaltodextrinDietary Supplement: Psyllium
- Registration Number
- NCT04829760
- Lead Sponsor
- University of Florida
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coarse wheat bran Coarse wheat bran 10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to a food they normally eat. Maltodextrin Maltodextrin Volume equivalent to the psyllium. Participants will be instructed to divide the daily dose into 2 doses and ingest by adding the product to a food or to 8 ounces (240 mL) of a beverage that is typically consumed. Psyllium Psyllium 10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to at least 8 ounces (240 mL) of cold water or a beverage that is typically consumed. Participants will ingest the intervention each morning and evening for eight weeks.
- Primary Outcome Measures
Name Time Method Body weight 8 weeks The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
- Secondary Outcome Measures
Name Time Method Digestive health Each week up to 10 weeks Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale, which is composed of 15 questions related to 5 syndromes: constipation, diarrhea, reflux, abdominal pain, and indigestion. Individual syndrome scores will be summed for a total score.
Stool frequency Each week up to 10 weeks Compare the number of stools per week between groups
Laxative use Each week up to 10 weeks Compare laxative use frequency and dosage between groups
Constipation-related Quality of Life 8 weeks Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Body composition 8 weeks Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Stool consistency Each day up to 10 weeks Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Parkinson's Disease- related Quality of life 8 weeks Changes in quality of life assessed by the Parkinson's disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39 questionnaire tool that assesses quality of life within the domains of activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, and social support.
Nutrition risk 8 weeks Changes in nutrition risk determined by the Patient Generated- Subjective Global Assessment (PG-SGA). The PG-SGA is a tool that helps clinicians determine nutrition risk by considering weight changes, changes in dietary intake, presence of nutrition impact symptoms, physical activity, comorbidities, metabolic demands, and an assessment of lean mass, fat mass, and edema.
Appetite Each week up to 10 weeks Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Non-motor symptoms 8 weeks Compare non-motor symptom severity and frequency over the past 1 month will be captured by the Non-Motor Symptom Scale for Parkinson's Disease (NMSS).
Handgrip strength 8 weeks Changes in upper body strength assessed by handgrip strength via dynamometer
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States