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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958734
• Other study ID #: HM20015510-1
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

.

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hyperlipidemias
• Lipemia

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Sigma Xi

Country where clinical trial is conducted

United States, 

Outcome

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