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

Primary Purpose

Cardiovascular Risk Factor, Lipemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-fat meal
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Risk Factor focused on measuring Vascular Dysfunction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low physical activity/fitness

High physical activity/fitness

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 17, 2019
Last Updated
April 11, 2022
Sponsor
Virginia Commonwealth University
Collaborators
Sigma Xi
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1. Study Identification

Unique Protocol Identification Number
NCT03958734
Brief Title
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Official Title
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Sigma Xi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Lipemia
Keywords
Vascular Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low physical activity/fitness
Arm Type
Other
Arm Description
Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.
Arm Title
High physical activity/fitness
Arm Type
Other
Arm Description
Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.
Intervention Type
Other
Intervention Name(s)
High-fat meal
Intervention Description
Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes
Primary Outcome Measure Information:
Title
Fasting triglycerides
Description
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Time Frame
Baseline
Title
Post HFM Triglycerides
Description
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Time Frame
4 hours
Title
Fasting total cholesterol
Description
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.
Time Frame
Baseline
Title
Post HFM total cholesterol
Description
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.
Time Frame
4 hours
Title
Fasting LDL
Description
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Time Frame
Baseline
Title
Post HFM LDL
Description
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Time Frame
4 hours
Title
Fasting HDL
Description
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Time Frame
Baseline
Title
Post HFM HDL
Description
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Time Frame
4 hours
Title
Fasting non-HDL
Description
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Time Frame
Baseline
Title
Post HFM non-HDL
Description
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Time Frame
4 hours
Title
Fasting LDL/HDL ratio
Description
Assessment of risk for heart disease.
Time Frame
Baseline
Title
Post HFM LDL/HDL ratio
Description
Assessment of risk for heart disease.
Time Frame
4 hours
Title
Fasting anti-inflammatory surface receptor expression
Description
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Time Frame
Baseline
Title
Post HFM anti-inflammatory surface receptor expression
Description
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Time Frame
4 hours
Title
Fasting pro-inflammatory surface receptor expression
Description
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Time Frame
Baseline
Title
Post HFM pro-inflammatory surface receptor expression
Description
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Time Frame
4 hours
Title
Fasting brachial artery flow-mediated dilation
Description
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Time Frame
Baseline
Title
Post HFM brachial artery flow-mediated dilation
Description
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Time Frame
5.5 hours
Title
Fasting superficial artery flow-mediated dilation
Description
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Time Frame
Baseline
Title
Post HFM superficial artery flow-mediated dilation
Description
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Time Frame
5.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. . Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Franco, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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