Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
1 other identifier
interventional
20
1 country
1
Brief Summary
Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
October 6, 2021
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedApril 27, 2022
April 1, 2022
4 months
October 6, 2021
April 22, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Postprandial glycemic response
Blood plasma glucose will be measured, (AUC)
Acute study: [4 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood plasma glucose will be measured, (C max)
Acute study: [4 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood plasma glucose will be measured, (t max)
Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)
Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)
Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)
Acute study: [4 hours of measurement after consumption of test food]
Secondary Outcomes (4)
Gastric emptying rate
Acute study: 4 hours of measurement after consumption of test food]
Appetite ratings (Visual Analog Scale, VAS)
Acute study: [4 hours of measurement after consumption of test food]
Food Intake of the next meal
Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
Breath hydrogen (fermentability)
Acute study: [4 hours of measurement after consumption of test food]
Study Arms (6)
Rice flour
EXPERIMENTALRapidly digestible control
Alternanoligosaccharide 15
EXPERIMENTALWaxy potato starch
EXPERIMENTALCombination of waxy potato starch and epigallocatechin gallate (EGCG)
EXPERIMENTALCombination of chickpea flour and epigallocatechin gallate (EGCG)
EXPERIMENTALInulin
EXPERIMENTALInterventions
Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Retrograded waxy potato starch made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
A combination of retrograded waxy potato starch and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
A combination of chickpea flour and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, 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)
You may not qualify if:
- Pregnant or nursing women
- Diabetic
- Individuals with history of gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- Société des Produits Nestlé (SPN)collaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce R Hamaker, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- 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
October 6, 2021
First Posted
April 27, 2022
Study Start
November 10, 2021
Primary Completion
February 24, 2022
Study Completion
February 24, 2022
Last Updated
April 27, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made available to other researchers.