Slowly Digestible Carbohydrates and the Ileal Brake

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630445
• Other study ID #: 1502015807
• Status: Completed
• Phase: N/A
• Start date: June 2, 2015
• Est. completion date: July 31, 2015

Study information

• Verified date: March 2021
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Isomaltooligosaccharides (IMOs)
Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
• Xtend® sucromalt
Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
• 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.
• Raw corn starch
Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
• Maltodextrin
Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	General Mills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rate	Breath test was performed using 13C-octanoic acid mixed into test meals	Acute study; 4 hours of measurement after consumption of test food
Primary	Glycemic response	Blood glucose was measured using a continuous glucose monitor	Acute study; 4 hours of measurement after consumption of test food
Primary	Appetite ratings (Visual Analog Scale, VAS)	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	Breath hydrogen (fermentability)	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