The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Psyllium
* Dietary Supplement: Coarse wheat bran
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, single-blind, placebo-controlled parallel study in which participants consume 10 grams of psyllium, coarse wheat bran, or a placebo (maltodextrin) for eight weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psyllium<br>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. | Dietary Supplement: Psyllium<br>* Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks<br>|
| Experimental: Coarse wheat bran<br>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. | Dietary Supplement: Coarse wheat bran<br>* Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks<br>|
| Placebo Comparator: Maltodextrin<br>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. | Dietary Supplement: Maltodextrin<br>* Participants will consume maltodextrin in a volume equivalent to the psyllium intervention ( 2 tablespoons) in two doses each day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive health | 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. | Each week up to 10 weeks | 
| Laxative use | Compare laxative use frequency and dosage between groups | Each week up to 10 weeks | 
| Stool frequency | Compare the number of stools per week between groups | Each week up to 10 weeks | 
| Stool consistency | Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups | Each day up to 10 weeks | 
| Body composition | Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy. | 8 weeks | 
| Appetite | Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ). | Each week up to 10 weeks | 
| Nutrition risk | 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. | 8 weeks | 
| Constipation-related Quality of Life | Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire. | 8 weeks | 
| Non-motor symptoms | 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). | 8 weeks | 
| Parkinson's Disease- related Quality of life | 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. | 8 weeks | 
| Handgrip strength | Changes in upper body strength assessed by handgrip strength via dynamometer | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease