Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior
• Intervention / Treatment: Other: Rice flour; Other: Alternanoligosaccharide 15; Other: Waxy potato starch; Other: Waxy potato starch + epigallocatechin gallate (EGCG); Other: Chickpea flour + epigallocatechin gallate (EGCG); Other: Inulin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inulin	Other: Inulin; Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Experimental: Rice flour; Rapidly digestible control	Other: Rice flour; Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Experimental: Alternanoligosaccharide 15	Other: Alternanoligosaccharide 15; Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Experimental: Waxy potato starch	Other: Waxy potato starch; 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.
Experimental: Combination of waxy potato starch and epigallocatechin gallate (EGCG)	Other: Waxy potato starch + epigallocatechin gallate (EGCG); 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.
Experimental: Combination of chickpea flour and epigallocatechin gallate (EGCG)	Other: Chickpea flour + epigallocatechin gallate (EGCG); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying rate	Breath test will be performed using 13C-acetate mixed into test meals	Acute study: 4 hours of measurement after consumption of test food]
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.	Acute study: [4 hours of measurement after consumption of test food]
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.	Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
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.	Acute study: [4 hours of measurement after consumption of test food]

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Bruce R Hamaker, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 24, 2022

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Neuroprotective Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Antimutagenic Agents; Epigallocatechin gallate
• Other Study ID Numbers: IRB-2020-986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No