Role of Colonic Short Chain Fatty Acids in Obesity

September 28, 2015 updated by: Thomas Wolever, University of Toronto

Effect of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin and Gut Hormone Responses in Lean and Overweight Subjects.

The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. The investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • non-pregnant
  • body mass index >=20 and <=35

Exclusion Criteria:

  • history of diabetes mellitus
  • history of cardiovascular disease
  • history of bowel disease
  • history of kidney disease
  • history of liver disease
  • use of antibiotics within 3 months of enrolment
  • unusual dietary habits
  • fasting glucose >6.9mmol/L
  • hematocrit below normal range for age and sex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lean
Participants with body mass index <=25
Other: Glucose
75g glucose
Other: Inulin
75g glucose plus 24g inulin
Other: Resistant Starch
75g glucose plus 28.2g resistant starch
Other: Overweight
Participants with body mass index >25
Other: Glucose
75g glucose
Other: Inulin
75g glucose plus 24g inulin
Other: Resistant Starch
75g glucose plus 28.2g resistant starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incremental area under the serum acetate response curve
Time Frame: For 6 hours after consuming the test meal
For 6 hours after consuming the test meal

Secondary Outcome Measures

Outcome Measure
Time Frame
Incremental area under the serum propionate response curve
Time Frame: For 6 hours after consuming the test meal
For 6 hours after consuming the test meal
Incremental area under the serum butyrate response curve
Time Frame: For 6 hours after consuming the test meal
For 6 hours after consuming the test meal
Incremental area under the breath hydrogen response curve
Time Frame: For 6 hours after consuming the test meal
For 6 hours after consuming the test meal
Incremental area under the breath methane response curve
Time Frame: For 6 hours after consuming the test meal
For 6 hours after consuming the test meal
Incremental area under the serum glucose response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum glucose response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch
Incremental area under the serum insulin response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum insulin response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch
Incremental area under the serum c-peptide response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum c-peptide response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch
Total area under the serum free-fatty acid response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Total area under the serum free-fatty acid response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch

Other Outcome Measures

Outcome Measure
Time Frame
Incremental area under the serum glucagon-like peptide-1 response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum glucagon-like peptide-1 response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch
Incremental area under the serum peptide-YY response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum peptide-YY response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch
Incremental area under the serum ghrelin response curve
Time Frame: For 4 hours after consuming the test meal
For 4 hours after consuming the test meal
Incremental area under the serum ghrelin response curve
Time Frame: For 2 hours after consuming the standard lunch
For 2 hours after consuming the standard lunch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Thomas MS Wolever, MD, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol #27112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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