Clinical trial NCT03630445: Slowly Digestible Carbohydrates and the Ileal Brake
Official title: Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2018-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Gastric emptying rate
timeFrame: Acute study; 4 hours of measurement after consumption of test food
measure: Glycemic response
timeFrame: Acute study; 4 hours of measurement after consumption of test food
measure: Appetite ratings (Visual Analog Scale, VAS)
timeFrame: Acute study; 4 hours of measurement after consumption of test food
Secondary outcomes:
measure: Breath hydrogen (fermentability)
timeFrame: Acute study; 4 hours of measurement after consumption of test food
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Chegeni M, Hayes AMR, Gonzalez TD, Manderfeld MM, Lim J, Menon RS, Holschuh NM, Hedges ME, Hamaker BR. Activation of gastrointestinal ileal brake response with dietary slowly digestible carbohydrates, with no observed effect on subjective appetite, in an acute randomized, double-blind, crossover trial. Eur J Nutr. 2022 Jun;61(4):1965-1980. doi: 10.1007/s00394-021-02770-2. Epub 2022 Jan 26.