An interventional study of Potato starch in Bariatric Surgery Candidate, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Basic science
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.
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.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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Exclusion Criteria:
Participants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30.
Dietary Supplement: 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.
Gastrointestinal tolerance
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.
Time frame: 30 days
Short-chain fatty acid
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.
Time frame: 30 days
Hunger and food cravings
Test 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.
Time frame: 30 days
Plan to share: Yes — Metabolomics data will be uploaded to Metabolomics Workbench one year after receiving data. Clinical variables, dietary data, and survey responses will be available upon request to PI.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center