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Slowly Digestible Carbohydrates and the Ileal Brake

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isomaltooligosaccharides (IMOs)
Xtend® sucromalt
Combination of IMOs and Xtend® sucromalt
Raw corn starch
Maltodextrin
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Isomaltooligosaccharides (IMOs)

Xtend® sucromalt

Combination of IMOs and Xtend® sucromalt

Raw corn starch

Maltodextrin

Arm Description

Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal. IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.

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.

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

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.

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.

Outcomes

Primary Outcome Measures

Gastric emptying rate
Breath test was performed using 13C-octanoic acid mixed into test meals
Glycemic response
Blood glucose was measured using a continuous glucose monitor
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2018
Last Updated
March 8, 2021
Sponsor
Purdue University
Collaborators
General Mills
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1. Study Identification

Unique Protocol Identification Number
NCT03630445
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2015 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
July 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
General Mills

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isomaltooligosaccharides (IMOs)
Arm Type
Experimental
Arm Description
Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal. IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.
Arm Title
Xtend® sucromalt
Arm Type
Experimental
Arm Description
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.
Arm Title
Combination of IMOs and Xtend® sucromalt
Arm Type
Experimental
Arm Description
Combination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal.
Arm Title
Raw corn starch
Arm Type
Experimental
Arm Description
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.
Arm Title
Maltodextrin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Isomaltooligosaccharides (IMOs)
Intervention Description
Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Xtend® sucromalt
Intervention Description
Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Combination of IMOs and Xtend® sucromalt
Intervention Description
A combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Raw corn starch
Intervention Description
Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Primary Outcome Measure Information:
Title
Gastric emptying rate
Description
Breath test was performed using 13C-octanoic acid mixed into test meals
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Title
Glycemic response
Description
Blood glucose was measured using a continuous glucose monitor
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Title
Appetite ratings (Visual Analog Scale, VAS)
Description
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.
Time Frame
Acute study; 4 hours of measurement after consumption of test food
Secondary Outcome Measure Information:
Title
Breath hydrogen (fermentability)
Description
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.
Time Frame
Acute study; 4 hours of measurement after consumption of test food

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available to other researchers
Citations:
PubMed Identifier
35079895
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.
Results Reference
derived

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Slowly Digestible Carbohydrates and the Ileal Brake

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