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Completed

NCT Number: NCT03630445

Slowly Digestible Carbohydrates and the Ileal Brake

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isomaltooligosaccharides (IMOs)

Other

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

Xtend® sucromalt

Other

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

Combination of IMOs and Xtend® sucromalt

Other

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

Other

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

maltodextrin

Other

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

Primary outcomes

  1. Gastric emptying rate

    Time frame: Acute study; 4 hours of measurement after consumption of test food

    Breath test was performed using 13C-octanoic acid mixed into test meals

  2. Glycemic response

    Time frame: Acute study; 4 hours of measurement after consumption of test food

    Blood glucose was measured using a continuous glucose monitor

  3. Appetite ratings (Visual Analog Scale, VAS)

    Time frame: Acute study; 4 hours of measurement after consumption of test food

    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.

Secondary outcomes

  1. Breath hydrogen (fermentability)

    Time frame: Acute study; 4 hours of measurement after consumption of test food

    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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • General Mills

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2018
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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