Slowly Digestible Carbohydrates and the Ileal Brake

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-02

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Diabetes Mellitus, Type 2 Appetitive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Isomaltooligosaccharides (IMOs)

Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal.

IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.

Group Type EXPERIMENTAL

Isomaltooligosaccharides (IMOs)

Intervention Type OTHER

Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

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.

Group Type EXPERIMENTAL

Xtend® sucromalt

Intervention Type OTHER

Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Combination of IMOs and Xtend® sucromalt

Combination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal.

Group Type EXPERIMENTAL

Combination of IMOs and Xtend® sucromalt

Intervention Type OTHER

A combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

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.

Group Type EXPERIMENTAL

Raw corn starch

Intervention Type OTHER

Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

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.

Group Type EXPERIMENTAL

Maltodextrin

Intervention Type OTHER

Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Interventions

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Isomaltooligosaccharides (IMOs)

Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Intervention Type OTHER

Xtend® sucromalt

Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Intervention Type 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.

Intervention Type OTHER

Raw corn starch

Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Intervention Type OTHER

Maltodextrin

Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes