NCT03630263

Brief Summary

Consumption of slowly digestible carbohydrates can elicit higher satiety feeling compared to rapidly digestible carbohydrates, however not all individuals respond the same. The physiological mechanism that accounts for the satiety effect and the lack of consistency among subjects is not fully understood. The overall aim of this research is to determine if consumption of slow digestible carbohydrates can induce non-responding subjects (i.e., with rapid gastric emptying) to activate the ileal brake and delay rate of gastric emptying.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2019

Typical duration for not_applicable obesity

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.6 years

First QC Date

August 9, 2018

Last Update Submit

November 11, 2022

Conditions

ObesityDiabetes Mellitus, Type 2Appetitive Behavior

Keywords

Gastric emptyingPostprandial blood glucose

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying time

    13C octanoid acid labeled

    Acute measurement of gastric emptying (4 hours post test meal consumption)

  • Metabolic fuel utilization

    Measured using RER with Lumen

    Acute measures (2 hours post test meal consumption)

Secondary Outcomes (1)

  • Self reported satiety scores

    Acute measurement of satiety or hunger scores (4 hours post test meal consumption)

Study Arms (2)

Raw Corn Starch

EXPERIMENTAL

Vehicle (apple sauce) will be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)

Other: Raw Corn Starch

No Raw Corn Starch

PLACEBO COMPARATOR

Vehicle (apple sauce) will not be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)

Other: No Raw Corn Starch

Interventions

Raw Corn StarchOTHER

Raw corn starch (30 g) will be added to 200 g of applesauce and served to participants, gastric emptying rate, and postprandial glucose will be measured.

Raw Corn Starch
No Raw Corn StarchOTHER

200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.

No Raw Corn Starch

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5 - 25.0 kg/m2
  • years
  • Normal fasting blood glucose

You may not qualify if:

  • History of gastrointestinal disease
  • Diabetes
  • Pregnant and nursing women
  • Wheat and/or gluten allergies or sensitivities
  • Allergy to specific sources of slowly digestible carbohydrates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University Lyles Porter Room 1144

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Appetitive Behavior

Interventions

Starch

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

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
Masking Details
Participants will be provided with a sample that doesn't contain starch.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Repeated measures ANOVA, within factors.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Food Science; Roy L. Whistler Chair

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

May 1, 2019

Primary Completion

December 23, 2021

Study Completion

April 1, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)