Skip to main content
OpenTrials
Completed

NCT Number: NCT05349903

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Appetitive Behavior Behavior Behavior, Animal Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rice flour

Other

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

Other

Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.

Inulin

Other

Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.

Waxy potato starch

Other

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.

Waxy potato starch + epigallocatechin gallate (EGCG)

Other

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.

Chickpea flour + epigallocatechin gallate (EGCG)

Other

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 outcomes

  1. Postprandial glycemic response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucose will be measured, (AUC)

  2. Postprandial glycemic response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucose will be measured, (C max)

  3. Postprandial glycemic response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucose will be measured, (t max)

  4. Postprandial plasma gut hormone response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)

  5. Postprandial plasma gut hormone response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)

  6. Postprandial plasma gut hormone response

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)

Secondary outcomes

  1. Gastric emptying rate

    Time frame: Acute study: 4 hours of measurement after consumption of test food]

    Breath test will be performed using 13C-acetate mixed into test meals

  2. Appetite ratings (Visual Analog Scale, VAS)

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    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.

  3. Food Intake of the next meal

    Time frame: Acute study: After the consumption a second meal [4 hours later after consuming the first 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.

  4. Breath hydrogen (fermentability)

    Time frame: Acute study: [4 hours of measurement after consumption of test food]

    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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.