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

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04829760

Collaborator

(none)

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Dietary Supplement: Psyllium Dietary Supplement: Coarse wheat bran Dietary Supplement: Maltodextrin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 13, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psyllium 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 Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
Experimental: Coarse wheat bran 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 Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
Placebo Comparator: Maltodextrin 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 Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks

Arm

Intervention/Treatment

Experimental: Psyllium

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

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

Experimental: Coarse wheat bran

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

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

Placebo Comparator: Maltodextrin

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

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

Outcome Measures

Primary Outcome Measures

Body weight [8 weeks]
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.

Secondary Outcome Measures

Digestive health [Each week up to 10 weeks]
Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale, which is composed of 15 questions related to 5 syndromes: constipation, diarrhea, reflux, abdominal pain, and indigestion. Individual syndrome scores will be summed for a total score.
Laxative use [Each week up to 10 weeks]
Compare laxative use frequency and dosage between groups
Stool frequency [Each week up to 10 weeks]
Compare the number of stools per week between groups
Stool consistency [Each day up to 10 weeks]
Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Body composition [8 weeks]
Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Appetite [Each week up to 10 weeks]
Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Nutrition risk [8 weeks]
Changes in nutrition risk determined by the Patient Generated- Subjective Global Assessment (PG-SGA). The PG-SGA is a tool that helps clinicians determine nutrition risk by considering weight changes, changes in dietary intake, presence of nutrition impact symptoms, physical activity, comorbidities, metabolic demands, and an assessment of lean mass, fat mass, and edema.
Constipation-related Quality of Life [8 weeks]
Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Non-motor symptoms [8 weeks]
Compare non-motor symptom severity and frequency over the past 1 month will be captured by the Non-Motor Symptom Scale for Parkinson's Disease (NMSS).
Parkinson's Disease- related Quality of life [8 weeks]
Changes in quality of life assessed by the Parkinson's disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39 questionnaire tool that assesses quality of life within the domains of activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, and social support.
Handgrip strength [8 weeks]
Changes in upper body strength assessed by handgrip strength via dynamometer

Other Outcome Measures

Digestion-related Quality of Life [Each week up to 10 weeks]
Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire.
Stress [Each day up to 10 weeks]
Changes in daily stress rating on a 10-point severity Likert scale.
Physical Activity [8 weeks]
Changes in physical activity assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ assess the intensity of physical activity and sitting time to estimate total physical activity (Metabolic Equivalents-min/week).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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