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

Slowly Digestible Carbohydrates and the Ileal Brake

Sponsors

Lead sponsor: Purdue University

Collaborator: General Mills Inc.

Source Purdue University
Brief Summary

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.

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.

Overall Status Completed
Start Date June 2, 2015
Completion Date July 31, 2015
Primary Completion Date July 31, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Gastric emptying rate Acute study; 4 hours of measurement after consumption of test food
Glycemic response Acute study; 4 hours of measurement after consumption of test food
Secondary Outcome
Measure Time Frame
Appetite ratings (Visual Analog Scale, VAS) Acute study; 4 hours of measurement after consumption of test food
Breath hydrogen (fermentability) Acute study; 4 hours of measurement after consumption of test food
Enrollment 20
Condition
Intervention

Intervention type: Other

Intervention name: Isomaltooligosaccharides (IMOs)

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

Arm group label: Isomaltooligosaccharides (IMOs)

Intervention type: Other

Intervention name: Xtend® sucromalt

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

Arm group label: Xtend® sucromalt

Intervention type: Other

Intervention name: Combination of IMOs and Xtend® sucromalt

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

Arm group label: Combination of IMOs and Xtend® sucromalt

Intervention type: Other

Intervention name: Raw corn starch

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

Arm group label: Raw corn starch

Intervention type: Other

Intervention name: Maltodextrin

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

Arm group label: Maltodextrin

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: Accepts Healthy Volunteers

Location
facility Purdue University
Location Countries

United States

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Purdue University

Investigator full name: Bruce R. Hamaker

Investigator title: Distinguished Professor of Food Science

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Arm group label: Isomaltooligosaccharides (IMOs)

Arm group type: Experimental

Description: Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal. IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.

Arm group label: Xtend® sucromalt

Arm group type: Experimental

Description: 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.

Arm group label: Combination of IMOs and Xtend® sucromalt

Arm group type: Experimental

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

Arm group label: Raw corn starch

Arm group type: Experimental

Description: 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.

Arm group label: Maltodextrin

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov