Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1

NCT03958734 | Completed

• 1 other identifier: HM20015510-1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effect of high-fat meals on the health of blood vessels. In addition, the study will examine how exercise/fitness/physical activity impacts blood vessels after consumption of a high-fat meal.

Conditions

Cardiovascular Risk Factor; Lipemia

Keywords

Vascular Dysfunction

Outcome Measures

Primary Outcomes (20)

• Fasting triglycerides

  Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.

  Baseline

• Post HFM Triglycerides

  Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.

  4 hours

• Fasting total cholesterol

  Type of lipid that is required for cell structure, but can contribute to increased risk of heart disease if high due to development of fatty deposits on vascular wall.

  Baseline

• Post HFM total cholesterol

  Type of lipid that is required for cell structure, but can contribute to increased risk of heart disease if high due to development of fatty deposits on vascular wall.

  4 hours

• Fasting LDL

  Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.

  Baseline

• Post HFM LDL

  Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.

  4 hours

• Fasting HDL

  High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.

  Baseline

• Post HFM HDL

  High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.

  4 hours

• Fasting non-HDL

  Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.

  Baseline

• Post HFM non-HDL

  Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.

  4 hours

• Fasting LDL/HDL ratio

  Assessment of risk for heart disease.

  Baseline

• Post HFM LDL/HDL ratio

  Assessment of risk for heart disease.

  4 hours

• Fasting anti-inflammatory surface receptor expression

  CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  Baseline

• Post HFM anti-inflammatory surface receptor expression

  CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  4 hours

• Fasting pro-inflammatory surface receptor expression

  CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  Baseline

• Post HFM pro-inflammatory surface receptor expression

  CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  4 hours

• Fasting brachial artery flow-mediated dilation

  Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  Baseline

• Post HFM brachial artery flow-mediated dilation

  Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  5.5 hours

• Fasting superficial artery flow-mediated dilation

  Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  Baseline

• Post HFM superficial artery flow-mediated dilation

  Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  5.5 hours

Study Arms (2)

Low physical activity/fitness

OTHER

Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.

Other: High-fat meal

High physical activity/fitness

OTHER

Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.

Other: High-fat meal

Interventions

High-fat meal OTHER

Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes

High physical activity/fitness; Low physical activity/fitness

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• college-age: 18-30 years old
• normal fasting triglyceride (\<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).
• normal body composition: % body fat, males \<25%, females \<32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)
• self-reported engagement in moderate-vigorous intensity physical activity and/or an exercise training regimen OR self-reported low physical activity and no engagement in an exercise training regimen (International Physical Activity Questionnaire)
• low cardiorespiratory fitness (VO2peak; male: =\<45 mL/kg/min; female: =\<35 mL/kg/min; categorized as =40th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) OR high cardiorespiratory fitness (VO2peak; male: =55 mL/kg/min; female: 45 mL/kg/min; categorized as =70th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47)
• f.) for female participants, presence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods.

You may not qualify if:

• presence of diagnosed cardiovascular, metabolic, or renal disease or dysfunction
• presence of signs and symptoms suggestive of cardiovascular, metabolic, or renal disease
• presence of musculoskeletal injury
• pregnancy
• history of smoking
• engagement in an abnormal eating behavior
• unable to communicate effectively in English
• moderate cardiorespiratory fitness (VO2peak; male: 46-54 mL/kg/min; female: 36-44 mL/kg/min)
• elevated or high fasting triglycerides (\>150 mg/dL)
• absence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Sigma Xi: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert L Franco, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: June 17, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)