NCT04437459

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 8, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 15, 2020

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reliability of the Change in Triglycerides after a High-Fat Meal

    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

    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.

Study Arms (2)

Abbreviated Fat Tolerance Test

EXPERIMENTAL
Other: High-fat shake

Oral Glucose Tolerance Test

ACTIVE COMPARATOR
Other: Pure glucose solution

Interventions

Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.

Abbreviated Fat Tolerance Test

Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.

Oral Glucose Tolerance Test

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078-6104, United States

Location

MeSH Terms

Conditions

DyslipidemiasMetabolic Syndrome

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Sam R Emerson, PhD

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

October 8, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations