Clinical trial NCT04829760: The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Official title: The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Nutrition
Dietetics
Fiber
Weight loss
Constipation
Malnutrition
Parkinson's Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Body weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Digestive health
timeFrame: Each week up to 10 weeks
measure: Laxative use
timeFrame: Each week up to 10 weeks
measure: Stool frequency
timeFrame: Each week up to 10 weeks
measure: Stool consistency
timeFrame: Each day up to 10 weeks
measure: Body composition
timeFrame: 8 weeks
measure: Appetite
timeFrame: Each week up to 10 weeks
measure: Nutrition risk
timeFrame: 8 weeks
measure: Constipation-related Quality of Life
timeFrame: 8 weeks
measure: Non-motor symptoms
timeFrame: 8 weeks
measure: Parkinson's Disease- related Quality of life
timeFrame: 8 weeks
measure: Handgrip strength
timeFrame: 8 weeks
Other outcomes:
measure: Digestion-related Quality of Life
timeFrame: Each week up to 10 weeks
measure: Stress
timeFrame: Each day up to 10 weeks
measure: Physical Activity
timeFrame: 8 weeks
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: