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Slowly Digestible Carbohydrates and the Ileal Brake

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03630445
Enrollment
20
Registered
2018-08-14
Start date
2015-06-02
Completion date
2015-07-31
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetitive Behavior, Diabetes Mellitus, Type 2, Obesity

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.

Interventions

OTHERIsomaltooligosaccharides (IMOs)

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

OTHERXtend® sucromalt

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

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

OTHERMaltodextrin

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

Sponsors

General Mills
CollaboratorINDUSTRY
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric emptying rateAcute study; 4 hours of measurement after consumption of test foodBreath test was performed using 13C-octanoic acid mixed into test meals
Glycemic responseAcute study; 4 hours of measurement after consumption of test foodBlood glucose was measured using a continuous glucose monitor
Appetite ratings (Visual Analog Scale, VAS)Acute study; 4 hours of measurement after consumption of test foodHunger 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.

Secondary

MeasureTime frameDescription
Breath hydrogen (fermentability)Acute study; 4 hours of measurement after consumption of test foodBreath 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026