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

April 11, 2022 updated by: Virginia Commonwealth University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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.

.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting triglycerides
Time Frame: Baseline
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Baseline
Post HFM Triglycerides
Time Frame: 4 hours
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
4 hours
Fasting total cholesterol
Time Frame: 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.
Baseline
Post HFM total cholesterol
Time Frame: 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.
4 hours
Fasting LDL
Time Frame: Baseline
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Baseline
Post HFM LDL
Time Frame: 4 hours
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
4 hours
Fasting HDL
Time Frame: Baseline
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Baseline
Post HFM HDL
Time Frame: 4 hours
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
4 hours
Fasting non-HDL
Time Frame: Baseline
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Baseline
Post HFM non-HDL
Time Frame: 4 hours
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
4 hours
Fasting LDL/HDL ratio
Time Frame: Baseline
Assessment of risk for heart disease.
Baseline
Post HFM LDL/HDL ratio
Time Frame: 4 hours
Assessment of risk for heart disease.
4 hours
Fasting anti-inflammatory surface receptor expression
Time Frame: Baseline
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Baseline
Post HFM anti-inflammatory surface receptor expression
Time Frame: 4 hours
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
4 hours
Fasting pro-inflammatory surface receptor expression
Time Frame: Baseline
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Baseline
Post HFM pro-inflammatory surface receptor expression
Time Frame: 4 hours
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
4 hours
Fasting brachial artery flow-mediated dilation
Time Frame: Baseline
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Baseline
Post HFM brachial artery flow-mediated dilation
Time Frame: 5.5 hours
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
5.5 hours
Fasting superficial artery flow-mediated dilation
Time Frame: Baseline
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Baseline
Post HFM superficial artery flow-mediated dilation
Time Frame: 5.5 hours
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
5.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sigma Xi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert L Franco, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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