The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
NCT ID: NCT04829760
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2021-05-13
2024-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
Psyllium
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
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.
Coarse wheat bran
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
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.
Maltodextrin
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (\~2 tablespoons) in two doses each day for 8 weeks
Interventions
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Psyllium
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
Coarse wheat bran
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
Maltodextrin
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (\~2 tablespoons) in two doses each day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
85 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Bobbi Langkamp-Henken, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB202100363
Identifier Type: -
Identifier Source: org_study_id
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