Fiber Supplementation After Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— FSPB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653648
• Other study ID #: Study02001775
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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