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

NCT04829760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-20

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Psyllium

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

DIETARY_SUPPLEMENT

Coarse wheat bran

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

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

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Bobbi Langkamp-Henken, PhD, RD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2024-04-28
Completion
2024-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829760 on ClinicalTrials.gov