Fiber Supplementation After Bariatric Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Bariatric Surgery Candidate

Clinical Trial Details

NCT number	NCT05653648
Study type	Interventional
Source	Dartmouth-Hitchcock Medical Center
Contact
Status	Completed
Phase	N/A
Start date	February 13, 2023
Completion date	February 28, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fiber Supplementation After Bariatric Surgery — FSPB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms