NCT05349903

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

October 6, 2021

Last Update Submit

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

EXPERIMENTAL

Rapidly digestible control

Other: Rice flour

Alternanoligosaccharide 15

EXPERIMENTAL
Other: Alternanoligosaccharide 15

Waxy potato starch

EXPERIMENTAL
Other: Waxy potato starch

Combination of waxy potato starch and epigallocatechin gallate (EGCG)

EXPERIMENTAL
Other: Waxy potato starch + epigallocatechin gallate (EGCG)

Combination of chickpea flour and epigallocatechin gallate (EGCG)

EXPERIMENTAL
Other: Chickpea flour + epigallocatechin gallate (EGCG)

Inulin

EXPERIMENTAL
Other: Inulin

Interventions

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

Rice flour

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

Alternanoligosaccharide 15
InulinOTHER

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

Inulin

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

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.

Combination of waxy potato starch and 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.

Combination of chickpea flour and epigallocatechin gallate (EGCG)

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive BehaviorObesityDiabetes Mellitus, Type 2

Interventions

FlourInulinepigallocatechin gallate

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Bruce R Hamaker, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

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.

Locations