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

Not Applicable

Completed

• Conditions: Lipemia; Cardiovascular Risk Factor
• Interventions: Other: High-fat meal

• Registration Number: NCT03958734
• Lead Sponsor: Virginia Commonwealth University

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.

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 Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-22
• Study Start: 2019-06-17
• Primary Completion: 2021-04-29
• Study Completion: 2021-04-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High physical activity/fitness	High-fat meal	Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.
Low physical activity/fitness	High-fat meal	Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.

Primary Outcome Measures

Name	Time	Method
Fasting LDL/HDL ratio	Baseline	Assessment of risk for heart disease.
Post HFM superficial artery flow-mediated dilation	5.5 hours	Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Post HFM total cholesterol	4 hours	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.
Post HFM HDL	4 hours	High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Post HFM LDL/HDL ratio	4 hours	Assessment of risk for heart disease.
Post HFM Triglycerides	4 hours	Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Fasting HDL	Baseline	High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Fasting non-HDL	Baseline	Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Fasting anti-inflammatory surface receptor expression	Baseline	CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM anti-inflammatory surface receptor expression	4 hours	CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting pro-inflammatory surface receptor expression	Baseline	CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM brachial artery flow-mediated dilation	5.5 hours	Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Fasting triglycerides	Baseline	Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Fasting total cholesterol	Baseline	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.
Fasting LDL	Baseline	Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Post HFM LDL	4 hours	Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Post HFM non-HDL	4 hours	Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Post HFM pro-inflammatory surface receptor expression	4 hours	CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting brachial artery flow-mediated dilation	Baseline	Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Fasting superficial artery flow-mediated dilation	Baseline	Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States