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

Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1

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.

Study Overview

• Status: Completed
• Conditions: Lipemia; Cardiovascular Risk Factor
• Intervention / Treatment: Other: High-fat meal

Detailed Description

This is the first in a series of studies examining the impact of high-fat meals on blood vessels. During the preliminary visit of this study, eligible participants' resting metabolic rate, arm flow mediated dilation, and leg flow mediate dilation will be measured. They will complete handgrip and plantar flexion exercise tasks. Finally, they will be given a physical activity monitor to wear for 7 days. At their first visit, participants will eat a high-fat meal and blood will be drawn to measure blood vessel health. They will also repeat the arm flow mediated dilation, leg flow mediate dilation, handgrip, and plantar flexion exercise tests.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. college-age: 18-30 years old
2. normal fasting triglyceride (<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).
3. normal body composition: % body fat, males <25%, females <32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)
4. 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)
5. 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.

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Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Low physical activity/fitness; Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.	Other: High-fat meal; Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes
OTHER: High physical activity/fitness; Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.	Other: High-fat meal; Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Sigma Xi
• Investigators: Principal Investigator: Robert L Franco, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2019
• Primary Completion (ACTUAL): April 29, 2021
• Study Completion (ACTUAL): April 29, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Vascular Dysfunction
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: HM20015510-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No