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Fiber Supplementation After Bariatric Surgery

Testing the Feasibility of Resistant Starch From Potatoes to Modify Short-chain Fatty Acid Levels After Bariatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05653648
Acronym
FSPB
Enrollment
30
Registered
2022-12-16
Start date
2023-02-13
Completion date
2024-02-28
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

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.

Interventions

DIETARY_SUPPLEMENTPotato 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.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal tolerance30 daysTest 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

MeasureTime frameDescription
Short-chain fatty acid30 daysTest 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.

Other

MeasureTime frameDescription
Hunger and food cravings30 daysTest hunger and food craving changes after a 30-day dose of potato starch in bariatric patients. Hunger and food cravings will be measured using the Control of Eating Questionnaire survey (Dalton et al, EJCN, 2015). Statistics will use paired t-test.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026