Slowly Digestible Carbohydrates and the Ileal Brake

March 8, 2021 updated by: Bruce R. Hamaker, Purdue University

Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response

The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diets containing slowly digestible carbohydrates (SDCs), in the form of starch-entrapped microspheres that digest into the ileum, were previously shown to reduce food intake in a diet-induced obese rat model by activating the gut-brain axis. These results suggested that SDCs trigger the ileal brake, which is a feedback mechanism controlling stomach-mediated transit of a meal. The ileal brake is characterized by delayed gastric emptying rate and increased satiety. The goal of this work was to determine if common SDCs trigger the ileal brake in humans, using gastric emptying rate as a proxy indicator. In a human study, SDCs were delivered through a semi-solid yogurt matrix, and gastric half-emptying time and postprandial glycemic response were assessed. The study was a five-arm, double-blind, crossover design with a one-week washout period between treatments (n=20, 9 females, 11 males). Four different carbohydrate ingredients (SDCs: isomalto-oligosaccharides (IMO), Xtend® sucromalt, and raw corn starch; and non-SDC: maltodextrin) were incorporated individually, or in combination, into yogurt products matched in energy density and viscosity. Participants consumed 300 g test meals of yogurt formulated with one or a combination of the carbohydrate ingredients after an overnight fast. Gastric emptying rates and glycemic response were measured using a 13C-labeled octanoic acid breath test and continuous glucose monitors, respectively. Glucose readings were continuously monitored 24 h prior to and 48 h after test meal consumption, and breath samples were collected for a 4 h period following test meal consumption.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5 - 25 kg/m2
  • Stable weight for the past 3 months (i.e. +/- 2..5 kg)
  • Regular eating patterns, including breakfast consumption

Exclusion Criteria:

  • Gastrointestinal disease
  • Smokers
  • Peri- or post-menopausal women
  • Celiac disease (yogurts may contain ingredients with wheat origin)
  • Allergies, including dairy, lactose, and gluten
  • Pregnant and lactating women
  • Following a weight reduction program or having followed one during the last 3 months
  • Acute or chronic disease
  • Alcohol consumption > 30 units/week
  • Hypertension
  • Diabetes
  • Previous bariatric surgery

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isomaltooligosaccharides (IMOs)

Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal.

IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.
Other: Isomaltooligosaccharides (IMOs)
Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Experimental: Xtend® sucromalt

Xtend® sucromalt incorporated into a yogurt test meal.

Sucromalt is derived from a combination of sucrose (cane or beet sugar) and maltose (corn sugar), yet it has been found to be slowly digested.
Other: Xtend® sucromalt
Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Experimental: Combination of IMOs and Xtend® sucromalt
Combination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal.
Other: Combination of IMOs and Xtend® sucromalt
A combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Experimental: Raw corn starch

Raw corn starch incorporated into a yogurt test meal.

Raw corn starch is uncooked starch from corn. Because it is not cooked, it has a slow digestion property.
Other: Raw corn starch
Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Experimental: Maltodextrin

Maltodextrin incorporated into a yogurt test meal.

Maltodextrin is a type of starchy carbohydrate (polysaccharide) composed of units of D-glucose (simple sugars). The maltodextrin used for this study had a fast digestion property.
Other: Maltodextrin
Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying rate
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Breath test was performed using 13C-octanoic acid mixed into test meals
Acute study; 4 hours of measurement after consumption of test food
Glycemic response
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Blood glucose was measured using a continuous glucose monitor
Acute study; 4 hours of measurement after consumption of test food
Appetite ratings (Visual Analog Scale, VAS)
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Hunger and fullness scores were measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness indicate better outcomes.
Acute study; 4 hours of measurement after consumption of test food

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath hydrogen (fermentability)
Time Frame: Acute study; 4 hours of measurement after consumption of test food
Breath samples were collected in 15-minute intervals for 4 hours after consumption of test food and analyzed for hydrogen levels using a breath analyzer. Breath hydrogen levels are indicative of a food's fermentability.
Acute study; 4 hours of measurement after consumption of test food

Collaborators and Investigators

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

Sponsor

Purdue University

Collaborators

General Mills

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 (Actual)

June 2, 2015

Primary Completion (Actual)

July 31, 2015

Study Completion (Actual)

July 31, 2015

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502015807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be made available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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