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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psyllium
Coarse wheat bran
Maltodextrin
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Psyllium

Coarse wheat bran

Maltodextrin

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Digestive health
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
Compare laxative use frequency and dosage between groups
Stool frequency
Compare the number of stools per week between groups
Stool consistency
Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Body composition
Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Appetite
Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Nutrition risk
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
Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Non-motor symptoms
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
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
Changes in upper body strength assessed by handgrip strength via dynamometer

Full Information

First Posted
March 31, 2021
Last Updated
September 19, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04829760
Brief Title
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Acronym
NRO
Official Title
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
April 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psyllium
Arm Type
Experimental
Arm 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.
Arm Title
Coarse wheat bran
Arm Type
Experimental
Arm 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.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Intervention Description
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Coarse wheat bran
Intervention Description
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks
Primary Outcome Measure Information:
Title
Body weight
Description
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Digestive health
Description
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.
Time Frame
Each week up to 10 weeks
Title
Laxative use
Description
Compare laxative use frequency and dosage between groups
Time Frame
Each week up to 10 weeks
Title
Stool frequency
Description
Compare the number of stools per week between groups
Time Frame
Each week up to 10 weeks
Title
Stool consistency
Description
Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Time Frame
Each day up to 10 weeks
Title
Body composition
Description
Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Time Frame
8 weeks
Title
Appetite
Description
Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Time Frame
Each week up to 10 weeks
Title
Nutrition risk
Description
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.
Time Frame
8 weeks
Title
Constipation-related Quality of Life
Description
Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Time Frame
8 weeks
Title
Non-motor symptoms
Description
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).
Time Frame
8 weeks
Title
Parkinson's Disease- related Quality of life
Description
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.
Time Frame
8 weeks
Title
Handgrip strength
Description
Changes in upper body strength assessed by handgrip strength via dynamometer
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Digestion-related Quality of Life
Description
Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire.
Time Frame
Each week up to 10 weeks
Title
Stress
Description
Changes in daily stress rating on a 10-point severity Likert scale.
Time Frame
Each day up to 10 weeks
Title
Physical Activity
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew P Beke, MS, RDN, LDN
Phone
352-340-7321
Email
nutrition-study@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobbi Langkamp-Henken, PhD, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Beke, MS, RDN, LDN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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