Fiber Supplementation After Bariatric Surgery (FSPB)

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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Dietary supplement: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Study02001775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available Jan 1, 2024 - indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No