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

University of Florida

Status: Completed

Conditions: Parkinson Disease

Treatments: Dietary Supplement: Coarse wheat bran; Dietary Supplement: Maltodextrin; Dietary Supplement: Psyllium

Study type: Interventional

Funder types: Other

Identifiers

NCT04829760

IRB202100363

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 3 patient groups, including a placebo group

Psyllium

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Psyllium

Coarse wheat bran

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Coarse wheat bran

Maltodextrin

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Maltodextrin