Lipid Challenge in Adults

NCT03948295 | Completed

• 1 other identifier: IRB00107183
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this study will have one visit to the Emory University Hospital Clinical Research Unit. Participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting (baseline) is followed by 5 time-points after fat consumption. Blood will be analyzed for a wide panel of blood lipids.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (26)

• Change in high-density lipoprotein (HDL) Size

  HDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. HDL is considered to be anti-atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in low-density lipoprotein (LDL) Size

  LDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. 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.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Total Cholesterol

  Total cholesterol profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. 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.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Free Cholesterol

  Free cholesterol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Cholesterol Ester

  Cholesterol ester concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Triglycerides

  Triglyceride concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Phosphatidylinositol

  Phosphatidylinositol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Phosphatidylethanolamine

  Phosphatidylethanolamine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Phosphatidylcholine

  Phosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Sphingomyelin

  Sphingomyelin concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Lysophosphatidylcholine

  Lysophosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein AI

  Apolipoprotein AI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein AII

  Apolipoprotein AII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein AIV

  Apolipoprotein AIV concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein B

  Apolipoprotein B concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein CI

  Apolipoprotein CI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein CII

  Apolipoprotein CII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein CIII

  Apolipoprotein CIII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Apolipoprotein E

  Apolipoprotein E concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Lecithin-Cholesterol Acyltransferase

  Lecithin-cholesterol acyltransferase concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Cholesterol Ester Transfer Protein

  Cholesterol ester transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Lipoprotein (a)

  Lipoprotein (a) concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Phospholipid Transfer Protein

  Phospholipid transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Serum Paraoxonase/arylesterase 1

  Serum paraoxonase/arylesterase 1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Serum Amyloid A1

  Serum amyloid A1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

• Change in Serum Amyloid A4

  Serum amyloid A4 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.

  Hours 0, 0.5, 1, 2, 4, and 6

Study Arms (1)

Lipid Challenge Intervention

EXPERIMENTAL

Participants of all weights will receive the lipid challenge intervention.

Dietary Supplement: Lipid Challenge

Interventions

Lipid Challenge DIETARY_SUPPLEMENT

After fasting for 10 hours, all participants will undergo a lipid challenge with Calogen. Calogen is a commercially available liquid high-energy long chain triglyceride fat emulsion used to fortify foods. Calogen provides 50 grams of long chain triglycerides per 100 mL. Participants must avoid physical activity during the 6 hour study period to avoid changes in metabolism that could affect the results of the study.

Also known as: Calogen

Lipid Challenge Intervention

Eligibility Criteria

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

You may qualify if:

• functionally ambulatory
• BMI between \>20 to 40 kg/m\^2
• available for an 8 hour visit to the Emory University Hospital Clinical Research Center

You may not qualify if:

• 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
• inability to provide informed consent

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

Study Officials

• Thomas R Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 13, 2019
• Study Start: August 29, 2019
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)