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
30 participants
INTERVENTIONAL
2023-02-13
2024-02-28
Brief Summary
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Detailed Description
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The objective of this protocol is to implement a 30-day fiber supplement, made from potato starch, as previous studies have successfully demonstrated that a resistant starch supplement increases intestinal SCFAs in healthy populations. The resistant starch supplement will be initiated 90-days post-bariatric surgery, which is when fiber supplements are tolerated. Fecal samples will be collected pre- and post-supplement and a targeted liquid chromatography/mass spectrometry platform will quantify levels of SCFAs. As SCFA levels have been associated with reduced hunger in other studies, the investigators will determine if hunger levels are altered in response to the supplement. The proposed study is described in the following aims:
Specific Aim 1. Assess compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients.
Specific Aim 2. Determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
Exploratory Aim. Determine if there are changes in dietary intake, appetite, and satiety in response to the dosages of potato starch.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Potato Starch Supplement
Participants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30.
Potato starch
Participants will consume 24 grams (days 1-15) and 48 grams (days 16-30) of potato starch. Potato starch is a type 2 resistant starch that is available over the counter.
Interventions
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Potato starch
Participants will consume 24 grams (days 1-15) and 48 grams (days 16-30) of potato starch. Potato starch is a type 2 resistant starch that is available over the counter.
Eligibility Criteria
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Inclusion Criteria
* Bariatric surgery at Dartmouth Medical Center
* Daily protein intake ≥ 60 grams
* Daily fluid intake ≥ 48 fl oz.
Exclusion Criteria
* Allergies to potato starches.
* Surgical complications per bariatric team members
* Individuals who cannot speak and/or write in English.
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Jennifer L. Meijer
Assistant Professor, Department of Medicine
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Other Identifiers
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Study02001775
Identifier Type: -
Identifier Source: org_study_id
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