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

Impact of Diet in Shaping Gastric Response and RER in Adults From Rural Africa and Urban USA

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior
• Intervention / Treatment: Other: Raw Corn Starch; Other: No Raw Corn Starch

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University Lyles Porter Room 1144

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raw Corn Starch; Vehicle (apple sauce) will be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)	Other: Raw Corn Starch; 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.
Placebo Comparator: No Raw Corn Starch; Vehicle (apple sauce) will not be spiked with 30 g of slowly digestible carbohydrate (raw corn starch)	Other: No Raw Corn Starch; 200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Acute measurement of satiety or hunger scores (4 hours post test meal consumption)

Collaborators and Investigators

• Sponsor: Purdue University
• Investigators: Principal Investigator: Bruce R Hamaker, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Gastric emptying; Postprandial blood glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-2019-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No