Slowly Digestible Carbohydrates and the Ileal Brake

Purdue University

Status: Completed

Conditions: Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2

Treatments: Other: Maltodextrin; Other: Combination of IMOs and Xtend® sucromalt; Other: Xtend® sucromalt; Other: Raw corn starch; Other: Isomaltooligosaccharides (IMOs)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03630445

1502015807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 5 patient groups

Isomaltooligosaccharides (IMOs)

Experimental group

Description:

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

Treatment:

Other: Isomaltooligosaccharides (IMOs)

Xtend® sucromalt

Experimental group

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.

Treatment:

Other: Xtend® sucromalt

Combination of IMOs and Xtend® sucromalt

Experimental group

Description:

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

Treatment:

Other: Combination of IMOs and Xtend® sucromalt

Raw corn starch

Experimental group

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.

Treatment:

Other: Raw corn starch

Maltodextrin

Experimental group

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.

Treatment:

Other: Maltodextrin