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Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

Primary Purpose

Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rice flour
Alternanoligosaccharide 15
Inulin
Waxy potato starch
Waxy potato starch + epigallocatechin gallate (EGCG)
Chickpea flour + epigallocatechin gallate (EGCG)
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetitive Behavior

Eligibility Criteria

22 Years - 45 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)

Exclusion Criteria:

  • Pregnant or nursing women
  • Diabetic
  • Individuals with history of gastrointestinal disease

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Rice flour

Alternanoligosaccharide 15

Waxy potato starch

Combination of waxy potato starch and epigallocatechin gallate (EGCG)

Combination of chickpea flour and epigallocatechin gallate (EGCG)

Inulin

Arm Description

Rapidly digestible control

Outcomes

Primary Outcome Measures

Postprandial glycemic response
Blood plasma glucose will be measured, (AUC)
Postprandial glycemic response
Blood plasma glucose will be measured, (C max)
Postprandial glycemic response
Blood plasma glucose will be measured, (t max)
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)

Secondary Outcome Measures

Gastric emptying rate
Breath test will be performed using 13C-acetate mixed into test meals
Appetite ratings (Visual Analog Scale, VAS)
Hunger and fullness scores will be 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.
Food Intake of the next meal
At the end of the 4 hour window, participants will be given a large second meal for consumption and the amount of consumed food (food intake) will be estimated.
Breath hydrogen (fermentability)
Breath samples will be 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
October 6, 2021
Last Updated
April 22, 2022
Sponsor
Purdue University
Collaborators
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT05349903
Brief Title
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Official Title
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Société des Produits Nestlé (SPN)

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
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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rice flour
Arm Type
Experimental
Arm Description
Rapidly digestible control
Arm Title
Alternanoligosaccharide 15
Arm Type
Experimental
Arm Title
Waxy potato starch
Arm Type
Experimental
Arm Title
Combination of waxy potato starch and epigallocatechin gallate (EGCG)
Arm Type
Experimental
Arm Title
Combination of chickpea flour and epigallocatechin gallate (EGCG)
Arm Type
Experimental
Arm Title
Inulin
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rice flour
Intervention Description
Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Alternanoligosaccharide 15
Intervention Description
Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Inulin
Intervention Description
Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Intervention Type
Other
Intervention Name(s)
Waxy potato starch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waxy potato starch + epigallocatechin gallate (EGCG)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chickpea flour + epigallocatechin gallate (EGCG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postprandial glycemic response
Description
Blood plasma glucose will be measured, (AUC)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Title
Postprandial glycemic response
Description
Blood plasma glucose will be measured, (C max)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Title
Postprandial glycemic response
Description
Blood plasma glucose will be measured, (t max)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Title
Postprandial plasma gut hormone response
Description
Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Title
Postprandial plasma gut hormone response
Description
Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Title
Postprandial plasma gut hormone response
Description
Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)
Time Frame
Acute study: [4 hours of measurement after consumption of test food]
Secondary Outcome Measure Information:
Title
Gastric emptying rate
Description
Breath test will be performed using 13C-acetate mixed into test meals
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 will be 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]
Title
Food Intake of the next meal
Description
At the end of the 4 hour window, participants will be given a large second meal for consumption and the amount of consumed food (food intake) will be estimated.
Time Frame
Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
Title
Breath hydrogen (fermentability)
Description
Breath samples will be 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
22 Years
Maximum Age & Unit of Time
45 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) Exclusion Criteria: Pregnant or nursing women Diabetic Individuals with history of gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce R Hamaker, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
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.

Learn more about this trial

Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

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