Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

Obesity Clinical Trial

Official title:

Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349903
• Other study ID #: IRB-2020-986
• Status: Completed
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Diabetes Mellitus, Type 2
• Obesity

Intervention

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.
• 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.
• Inulin
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
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)
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)
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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response	Blood plasma glucose will be measured, (AUC)	Acute study: [4 hours of measurement after consumption of test food]
Primary	Postprandial glycemic response	Blood plasma glucose will be measured, (C max)	Acute study: [4 hours of measurement after consumption of test food]
Primary	Postprandial glycemic response	Blood plasma glucose will be measured, (t max)	Acute study: [4 hours of measurement after consumption of test food]
Primary	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]
Primary	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]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]