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This Study Assessed the Impact of Diet on Gastric Emptying Time and Metabolic Flexibility (IODC)

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raw Corn Starch
No Raw Corn Starch
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Gastric emptying, Postprandial blood glucose

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 18.5 - 25.0 kg/m2
  • 18 - 50 years
  • Normal fasting blood glucose

Exclusion Criteria:

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

Sites / Locations

  • Purdue University Lyles Porter Room 1144

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Raw Corn Starch

No Raw Corn Starch

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gastric emptying time
13C octanoid acid labeled
Metabolic fuel utilization
Measured using RER with Lumen

Secondary Outcome Measures

Self reported satiety scores
Hunger and fullness scores using a 10 cm scale (0=weakest feeling of hunger or fullness; 10=highest or strongest feeling of hunger or fullness)

Full Information

First Posted
August 9, 2018
Last Updated
November 11, 2022
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT03630263
Brief Title
This Study Assessed the Impact of Diet on Gastric Emptying Time and Metabolic Flexibility
Acronym
IODC
Official Title
Impact of Diet in Shaping Gastric Response and RER in Adults From Rural Africa and Urban USA
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this study is to understand how diet may affect carbohydrate digestion, gastric emptying time and overall health. The investigators will be recruiting 32 volunteers for this study. To be eligible for this study, you need to be between 18 and 50 years old, have a normal Body Mass Index, have a normal fasting blood glucose level, be free of any gastrointestinal diseases, diabetes, cardiovascular diseases, be free of wheat allergens, gluten intolerance or sensitivities, and allergy to millet, and not be pregnant or nursing. If you have any questions about the criteria, please ask the person consenting you. In this study, participants will consume two test meals at different times to assess gastric emptying times. Test meals will consist of either corn starch (30 g) or pregelatinized (DE-1 Maltodextrin) starch in applesauce (200 g) with xanthan gum (0.2 g) to equalize viscosity. Ingredients will be mixed immediately before consumption. For assessment of gastric emptying time, we will use a non-invasive 13C-labeled octanoic acid breath test. In our proposed procedure, 13C octanoic acid will be added to test meals, and breath samples will be taken before and after ingestion up to 4 hours. Breath samples will be collected every 15 minutes for first 2 hours and every 30 minutes for the next 2 hours. Participants will breathe into 300 mL bags and their content will be evaluated for [13C] using a 13CO2 Urea Breath Analyzer POCone (Otsuka Electronics Co, Ltd, Osaka, Japan) as measures of gastric emptying. We have used the labeled substrate and breath collection methods in our lab under previously approved IRB protocols at Purdue University (IRB Protocols #1102010450, #1104010761, #1209012595, #1405014904, and #1502015807, #1611018484, #1706019377. In addition, before, during, and after each session, subjects will also be asked to fill out a short questionnaire with questions regarding your hunger and fullness at those times. Test meals will be prepared in the university with trained personnel. All the ingredients will be purchased from approved food manufacturers. During testing days participants will be required to stay in the laboratory. Testing day sessions will last about 4 hours. The day prior testing, participants will be provided a standard meal but are not required to stay. For assessment of diet composition, three 24-hour dietary recalls will be used. Participants will be called on three different days. During these sessions, participants will be asked to recount quantity and types of foods consumed throughout the day, including two weekdays and one weekend day, to form a comprehensive picture of their dietary habits. Dietary data will be collected and stored using no personally identifiable information. The purpose of this study is to evaluate the continuous effect of slowly digestible carbohydrates consumption on gastric emptying and its potential health benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
Keywords
Gastric emptying, Postprandial blood glucose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Repeated measures ANOVA, within factors.
Masking
Participant
Masking Description
Participants will be provided with a sample that doesn't contain starch.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raw Corn Starch
Arm Type
Experimental
Arm Description
Vehicle (apple sauce) will be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)
Arm Title
No Raw Corn Starch
Arm Type
Placebo Comparator
Arm Description
Vehicle (apple sauce) will not be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)
Intervention Type
Other
Intervention Name(s)
Raw Corn Starch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Raw Corn Starch
Intervention Description
200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.
Primary Outcome Measure Information:
Title
Gastric emptying time
Description
13C octanoid acid labeled
Time Frame
Acute measurement of gastric emptying (4 hours post test meal consumption)
Title
Metabolic fuel utilization
Description
Measured using RER with Lumen
Time Frame
Acute measures (2 hours post test meal consumption)
Secondary Outcome Measure Information:
Title
Self reported satiety scores
Description
Hunger and fullness scores using a 10 cm scale (0=weakest feeling of hunger or fullness; 10=highest or strongest feeling of hunger or fullness)
Time Frame
Acute measurement of satiety or hunger scores (4 hours post test meal consumption)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 18.5 - 25.0 kg/m2 18 - 50 years Normal fasting blood glucose Exclusion Criteria: History of gastrointestinal disease Diabetes Pregnant and nursing women Wheat and/or gluten allergies or sensitivities Allergy to specific sources of slowly digestible carbohydrates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce R Hamaker, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University Lyles Porter Room 1144
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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This Study Assessed the Impact of Diet on Gastric Emptying Time and Metabolic Flexibility

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