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

NCT04829760 | Completed

• 1 other identifier: IRB202100363
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Nutrition; Dietetics; Fiber; Weight loss; Constipation; Malnutrition; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Body weight

  The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.

  8 weeks

Secondary Outcomes (11)

• Digestive health

  Each week up to 10 weeks

• Laxative use

  Each week up to 10 weeks

• Stool frequency

  Each week up to 10 weeks

• Stool consistency

  Each day up to 10 weeks

• Body composition

  8 weeks

Other Outcomes (3)

• Digestion-related Quality of Life

  Each week up to 10 weeks

• Stress

  Each day up to 10 weeks

• Physical Activity

  8 weeks

Study Arms (3)

Psyllium

EXPERIMENTAL

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

Coarse wheat bran

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Interventions

Psyllium DIETARY_SUPPLEMENT

Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks

Psyllium

Coarse wheat bran DIETARY_SUPPLEMENT

Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks

Coarse wheat bran

Maltodextrin DIETARY_SUPPLEMENT

Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (\~2 tablespoons) in two doses each day for 8 weeks

Maltodextrin

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Weight Loss; Constipation; Malnutrition

Interventions

Psyllium; maltodextrin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: May 13, 2021
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)