Fiber Supplementation After Bariatric Surgery

NCT05653648 | Completed DMC

• 1 other identifier: Study02001775
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Short-chain fatty acid

  30 days

Other Outcomes (1)

• Hunger and food cravings

  30 days

Study Arms (1)

Potato Starch Supplement

EXPERIMENTAL

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

Interventions

Potato starch DIETARY_SUPPLEMENT

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.

Potato Starch Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 16, 2022
• Study Start: February 13, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available Jan 1, 2024 - indefinitely.

Locations

US (1)