Fiber Supplementation After Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate
• Interventions: Dietary Supplement: Potato starch

• Registration Number: NCT05653648
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.

Detailed Description

Despite the successful weight loss associated with bariatric surgery, epidemiology studies have observed conflicting associations between bariatric surgery and incidence of colorectal cancer (CRC), potentially suggesting an increased risk of CRC post-surgery. The investigators have identified a potential mechanism between bariatric surgery and CRC via profiling dietary intake, gut microbiota colonization, and short-chain fatty acid (SCFA) production, including acetate, propionate, and butyrate. They have demonstrated a decrease in SCFA after bariatric surgery. As intestinal SCFAs inhibit colon cancer cell proliferation, these results may suggest a mechanism linking bariatric surgery, SCFA levels, and CRC.

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.

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Study Start: 2023-02-13
• Status Verified: 2024-02
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults ≥ 18 years
• Bariatric surgery at Dartmouth Medical Center
• Daily protein intake ≥ 60 grams
• Daily fluid intake ≥ 48 fl oz.

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Exclusion Criteria

• > 550 lbs at bariatric surgery date.
• Allergies to potato starches.
• Surgical complications per bariatric team members
• Individuals who cannot speak and/or write in English.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Potato Starch Supplement	Potato starch	Participants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	30 days	Test gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients. Gastrointestinal tolerance will be measured using the GSRS survey (Svedlund et al, Digestive Diseases and Sciences, 1988). Statistics will use paired t-test.

Secondary Outcome Measures

Name	Time	Method
Short-chain fatty acid	30 days	Test changes in short-chain fatty acid levels from stool samples after a 30-day dose of potato starch in bariatric patients. Statistics will use paired t-test.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States