NCT04829760

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-05-13
• Primary completion: 2024-04-28
• Completion: 2024-04-28
• First posted: 2021-04-02
• Last updated: 2024-06-20

Locations

1 site across 1 country: United States