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
206 participants
INTERVENTIONAL
2004-04-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Placebo
basic recipe for juice and muffin recipe
abbreviated PLB
Placebo
Carboxymethylcellulose
The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily.
abbreviated CMC
carboxymethylcellulose
dietary fiber
Gum Arabic
The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily.
abbreviated GA
Gum Arabic
Gum acacia dietary fiber
Psyllium
The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily.
abbreviated as PSY
Psyllium
Interventions
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Psyllium
Gum Arabic
Gum acacia dietary fiber
carboxymethylcellulose
dietary fiber
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* living in the community (not a nursing home or assisted living facility)
* self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period
* toilets independently
* ability to read and write in English.
* Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI criteria were also eligible.
Exclusion Criteria
* a gastrointestinal (GI) tract altered by surgery,
* a malabsorption disorder,
* inflammatory bowel disease,
* gastrointestinal cancer or active cancer treatment,
* allergy to the fibers,
* regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications.
* a score ≤24 on the Mini Mental State Examination
* having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Donna Z Bliss, phD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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010M69241
Identifier Type: -
Identifier Source: org_study_id
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