The Mixed Meal Challenge Study

NCT05087823 | Completed

• 1 other identifier: IRB00116934
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases; Hyperlipidemias

Keywords

Prevention; Hyperlipidemia; Cardiovascular disease

Outcome Measures

Primary Outcomes (26)

• Change in high-density lipoprotein (HDL) Size

  HDL concentration size profiles for each time-point will be determined for each of the three meal challenges. HDL is considered to be anti- atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in low-density lipoprotein (LDL) Size

  LDL concentration size profiles for each time-point will be determined for each of the three meal challenges. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Total Cholesterol

  Total cholesterol profiles for each time-point will be determined for each of the three meal challenges. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Free Cholesterol

  Free cholesterol concentration for each time-point will be determined for each of the three meal challenges. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Cholesterol Ester

  Cholesterol ester concentration for each time-point will be determined for each of the three meal challenges. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Triglycerides

  Triglyceride concentration for each time-point will be determined for each of the three meal challenges. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Phosphatidylinositol

  Phosphatidylinositol concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Phosphatidylethanolamine

  Phosphatidylethanolamine concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Phosphatidylcholine

  Phosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Sphingomyelin

  Sphingomyelin concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Lysophosphatidylcholine

  Lysophosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein AI

  Apolipoprotein AI concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein AII

  Apolipoprotein AII concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein AIV

  Apolipoprotein AIV concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein B

  Apolipoprotein B concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein CI

  Apolipoprotein CI concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein CII

  Apolipoprotein CII concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein CIII

  Apolipoprotein CIII concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Apolipoprotein E

  Apolipoprotein E concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Lecithin-Cholesterol Acyltransferase

  Lecithin-cholesterol acyltransferase concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Cholesterol Ester Transfer Protein

  Cholesterol ester transfer protein concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Lipoprotein (a)

  Lipoprotein (a) concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Phospholipid Transfer Protein

  Phospholipid transfer protein concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Serum Paraoxonase/arylesterase 1

  Serum paraoxonase/arylesterase 1 concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Serum Amyloid A1

  Serum amyloid A1 concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

• Change in Serum Amyloid A4

  Serum amyloid A4 concentration for each time-point will be determined for each of the three meal challenges.

  Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)

Study Arms (1)

Lipid, Glucose, and Mixed Meal Challenges

EXPERIMENTAL

Participants will take part in three different meal challenges on three separate days with approximately two weeks in between. The first meal challenge is the lipid challenge, the second meal challenge is the glucose challenge and third meal challenge is the mixed-meal challenge.

Dietary Supplement: Lipid Challenge; Dietary Supplement: Glucose Challenge; Dietary Supplement: Mixed Meal Challenge

Interventions

Lipid Challenge DIETARY_SUPPLEMENT

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.

Also known as: Calogen

Lipid, Glucose, and Mixed Meal Challenges

Glucose Challenge DIETARY_SUPPLEMENT

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.

Lipid, Glucose, and Mixed Meal Challenges

Mixed Meal Challenge DIETARY_SUPPLEMENT

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.

Also known as: Ensure Enlive

Lipid, Glucose, and Mixed Meal Challenges

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any adult (18 -50 years) may participate who agrees to complete the following requirements:
• Be functionally ambulatory
• Have a body mass index (BMI) between \>20 kg/m2 to \<40 kg/m2
• Be available for an 8-hour visit to the Emory University Hospital Clinical Research Center
• Be able to fast for 10 hours prior to visiting Emory University Hospital Clinical Research Unit for each meal challenge

You may not qualify if:

• Vulnerable populations which include children, pregnant women, individuals with mental disabilities, and prisoners will be excluded from the study.
• Individuals with history of GI symptoms or fat intolerance will be excluded from the study.
• Individuals with health condition that would put them in risk due to 10 hour fasting, including:
• Has taken any diabetic or lipid lowering prescription medications within the past 12 months
• History of chronic diseases
• Hospitalized within the last year
• Currently pregnant
• Current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
• Current chronic autoimmune or pro-inflammatory disease
• History of tuberculosis, HIV, or other chronic infection
• Previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
• Advanced (\>= stage 3) renal disease
• Recreational or prescription drug or alcohol abuse
• Any history of gastrointestinal diseases, including malabsorption
• Any history of intolerance to dietary fat

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thomas Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 21, 2021
• Study Start: November 2, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)