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Trial record 3 of 3 for:    isomaltooligosaccharide

Slowly Digestible Carbohydrates and the Ileal Brake

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ClinicalTrials.gov Identifier: NCT03630445
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
Bruce R. Hamaker, Purdue University

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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Mellitus, Type 2 Appetitive Behavior Other: Isomaltooligosaccharides (IMOs) Other: Xtend® sucromalt Other: Combination of IMOs and Xtend® sucromalt Other: Raw corn starch Other: Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : July 31, 2015

Arm Intervention/treatment
Experimental: Isomaltooligosaccharides (IMOs)

Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal.

IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.

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

Experimental: Xtend® sucromalt

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.

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

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

Experimental: Raw corn starch

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.

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

Experimental: Maltodextrin

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.

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




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630445


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
General Mills Inc.

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Responsible Party: Bruce R. Hamaker, Distinguished Professor of Food Science, Purdue University
ClinicalTrials.gov Identifier: NCT03630445     History of Changes
Other Study ID Numbers: 1502015807
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases