The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test

• Sponsor: Oklahoma State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04437459
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias; Metabolic Syndrome	Other: High-fat shake; Other: Pure glucose solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
• Actual Study Start Date: Oct 8, 2018
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reliability of the Change in Triglycerides after a High-Fat Meal [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.

2. Reliability of the Change in Glucose after Ingestion of a Glucose Solution [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oklahoma State University	Stillwater	Oklahoma	United States	74078-6104

Sponsors and Collaborators

• Oklahoma State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oklahoma State University
• ClinicalTrials.gov Identifier: NCT04437459
• Other Study ID Numbers: HS1844
• First Posted: Jun 18, 2020
• Last Update Posted: Jun 18, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Dyslipidemias

Study Results

No Results Posted as of Jun 18, 2020