Slowly Digestible Carbohydrates and the Ileal Brake
Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2015
CompletedFirst Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedMarch 10, 2021
March 1, 2021
2 months
June 27, 2018
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Gastric emptying rate
Breath test was performed using 13C-octanoic acid mixed into test meals
Acute study; 4 hours of measurement after consumption of test food
Glycemic response
Blood glucose was measured using a continuous glucose monitor
Acute study; 4 hours of measurement after consumption of test food
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.
Acute study; 4 hours of measurement after consumption of test food
Secondary Outcomes (1)
Breath hydrogen (fermentability)
Acute study; 4 hours of measurement after consumption of test food
Study Arms (5)
Isomaltooligosaccharides (IMOs)
EXPERIMENTALIsomaltooligosaccharides (IMOs) incorporated into a yogurt test meal. IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property.
Xtend® sucromalt
EXPERIMENTALXtend® 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
EXPERIMENTALCombination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal.
Raw corn starch
EXPERIMENTALRaw 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
EXPERIMENTALMaltodextrin 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.
Interventions
Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
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.
Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Eligibility Criteria
You may qualify if:
- BMI 18.5 - 25 kg/m2
- Stable weight for the past 3 months (i.e. +/- 2..5 kg)
- Regular eating patterns, including breakfast consumption
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- General Millscollaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Related Publications (1)
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.
PMID: 35079895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor of Food Science
Study Record Dates
First Submitted
June 27, 2018
First Posted
August 14, 2018
Study Start
June 2, 2015
Primary Completion
July 31, 2015
Study Completion
July 31, 2015
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made available to other researchers