NCT06763562

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress90%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

January 2, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 19, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

January 2, 2025

Last Update Submit

February 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory exchange ratio

    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 Outcomes (4)

  • Fat use

    90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)

  • Carbohydrate use

    90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)

  • Blood glucose

    90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)

  • Hunger-satiety perceptions

    90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)

Study Arms (2)

Carbohydrate-first meal

EXPERIMENTAL
Other: Carbohydrate-first meal

Carbohydrate-last meal

EXPERIMENTAL
Other: Carbohydrate-last meal

Interventions

Rice eaten first (150 grams), followed by edamame (150 grams) and butter (10 grams)

Carbohydrate-first meal

Edamame (150 grams) and butter (10 grams) eaten first, followed by rice (150 grams)

Carbohydrate-last meal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Dominion University Human Performance Laboratory

Norfolk, Virginia, 23529, United States

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Patrick Wilson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Exercise Science

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

January 5, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 19, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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).

Time Frame
Data will become available once the associated article is officially published. The data will be made available indefinitely.

Locations