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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Dietary supplement: Psyllium; Dietary supplement: Coarse wheat bran; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digestion-related Quality of Life	Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire.	Each week up to 10 weeks
Stress	Changes in daily stress rating on a 10-point severity Likert scale.	Each day up to 10 weeks
Physical Activity	Changes in physical activity assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ assess the intensity of physical activity and sitting time to estimate total physical activity (Metabolic Equivalents-min/week).	8 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Bobbi Langkamp-Henken, PhD, RD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): April 28, 2024
• Study Completion (Actual): April 28, 2024

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Constipation; Parkinson's Disease; Fiber; Nutrition; Weight loss; Malnutrition; Dietetics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Body Weight; Constipation; Gastrointestinal Agents; Cathartics; Psyllium
• Other Study ID Numbers: IRB202100363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No