- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06763562
Food Orders on Blood Glucose and Fuel Use At Rest
February 16, 2025 updated by: Patrick Wilson, PhD, Old Dominion University
The Impact of Different Food Orders on Blood Glucose and Fuel Use At Rest
Consuming a carbohydrate-rich food as the final food in a meal, as compared to the first food in a meal, has been shown to reduce blood glucose levels after eating in both diabetes patients and in healthy controls.
However, gaps remain in the literature in this area of research, and currently little is known about how substrate (fuel) use is impacted by altering food order.
In addition, most studies to date have used a mix of meat and plant foods, while little research has focused exclusively on vegetarian foods.
This randomized experiment will examine how altering the order of foods eaten in a vegetarian meal impacts blood glucose and fuel utilization at rest.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrick Wilson, PhD
- Phone Number: 757-683-4783
- Email: pbwilson@odu.edu
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Recruiting
- Old Dominion University Human Performance Laboratory
-
Contact:
- Patrick Wilson, PhD
- Email: pbwilson@odu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-70 years old
- Free from any allergy or condition that precluding consumption of edamame, butter, and rice
- Not currently pregnant
- Free of any medical conditions requiring the use of insulin
- Have no history of bariatric surgery
- Have no implanted electrical devices such as a pacemaker
Exclusion Criteria:
- Younger than 18 and older than 70 years old
- Having an allergy or condition that precludes consumption of edamame, butter, and rice
- Currently pregnant
- Any medical conditions requiring the use of insulin
- A history of bariatric surgery
- Having an implanted electrical device such as a pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbohydrate-first meal
|
Rice eaten first (150 grams), followed by edamame (150 grams) and butter (10 grams)
|
|
Experimental: Carbohydrate-last meal
|
Edamame (150 grams) and butter (10 grams) eaten first, followed by rice (150 grams)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory exchange ratio
Time Frame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
Ratio of carbon dioxide production and oxygen consumption for determination of fuel use
|
90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat use
Time Frame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
Fat utilization will be estimated from respiratory gas exchange
|
90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
|
Carbohydrate use
Time Frame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
Carbohydrate utilization will be estimated from respiratory gas exchange
|
90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
|
|
Blood glucose
Time Frame: 90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
|
Blood glucose will be measured with fingerstick samples and a portable glucometer
|
90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
|
|
Hunger-satiety perceptions
Time Frame: 90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
|
Hunger, appetite, satiety, and fullness on a 0-10 Likert scale
|
90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
January 2, 2025
First Submitted That Met QC Criteria
January 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 16, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified IPD will be shared as supplementary material associated with the published peer-reviewed publication or through a publicly available repository (depending on the journal's preference).
IPD Sharing Time Frame
Data will become available once the associated article is officially published.
The data will be made available indefinitely.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.