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

Last updated: June 18, 2024
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

Constipation

Treatment

Coarse wheat bran

Maltodextrin

Psyllium

Clinical Study ID

NCT04829760
IRB202100363
  • Ages 40-85
  • All Genders

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.

Eligibility Criteria

Inclusion

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 theduration of the study protocol

  • Hoehn & Yahr stage < 4 in the clinical "ON" state

  • Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1months (≥ 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 interventionperiod

  • 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 beforeeach study visit

Exclusion

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 thanconstipation, gastroparesis, gastroesophageal reflux disease, or diverticulardisease

Study Design

Total Participants: 35
Treatment Group(s): 3
Primary Treatment: Coarse wheat bran
Phase:
Study Start date:
May 13, 2021
Estimated Completion Date:
April 28, 2024

Connect with a study center

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

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