The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test

June 16, 2020 updated by: Oklahoma State University
This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The reliability of the triglyceride results in this test are compared to the reliability of the glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically accepted metabolic test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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 Locations

  • United States
    • Oklahoma
      • Stillwater, Oklahoma, United States, 74078-6104
        • Oklahoma State University

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Free of chronic disease
  • Normal (healthy) fasting glucose and triglycerides

Exclusion Criteria:

  • Presence of pace-maker
  • Pregnant
  • Using tobacco products
  • Using medications or dietary supplements that could modify primary outcomes

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abbreviated Fat Tolerance Test
Other: High-fat shake
Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
Active Comparator: Oral Glucose Tolerance Test
Other: Pure glucose solution
Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the Change in Triglycerides after a High-Fat Meal
Time Frame: The two fat tolerance tests are separated by 1 week.
Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.
The two fat tolerance tests are separated by 1 week.
Reliability of the Change in Glucose after Ingestion of a Glucose Solution
Time Frame: The two glucose tolerance tests are separated by 1 week.
Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.
The two glucose tolerance tests are separated by 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University

Investigators

  • Principal Investigator: Sam R Emerson, PhD, Oklahoma State University

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)

October 8, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS1844

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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