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The Mixed Meal Challenge Study

NCT05087823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-05-01

No results posted yet for this study

Summary

The purpose of this study is to assess sample collection conditions for various dietary challenges (fat, sugar, and mixed) and determine the optimal fasting and post-meal sample collection time points for future studies on a larger group of individuals. Study participants will attend three study visits where they take part in lipid, glucose, and mixed meal challenges. At each of the three visits, participants will provide venous blood samples and a urine sample before consuming the test meal and will provide 6 additional venous finger blood samples post-meal.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lipid Challenge

For the lipid challenge, participants consume 100 grams of a long chain triglyceride emulsion in the form of liquid drink, which is the commercially available brand called Calogen, from Nutricia, Inc.

DIETARY_SUPPLEMENT

Glucose Challenge

For the glucose challenge, participants consume 75 grams of glucose in 200 milliliters of water, which is the World Health Organization (WHO) recommended drink for the Oral Glucose Tolerance Test.

DIETARY_SUPPLEMENT

Mixed Meal Challenge

For the mixed-meal challenge, participants consume 237 milliliters of the Ensure Enlive nutrition drink , which contains 11 grams of fat, 22 grams of sugar and 20 grams of protein.

Sponsors & Collaborators

Principal Investigators

  • Thomas Ziegler, MD · Emory University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2022-05-19
Completion
2022-05-19

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087823 on ClinicalTrials.gov