Cardiovascular Risk FactorNCT03958734
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
A study testing High-fat meal in people with Cardiovascular Risk Factor and Lipemia, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Lipemia
- What is being tested?
- High-fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- .
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Lipemia
- Being tested
- High-fat meal
- Keywords
- Vascular Dysfunction
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat mealOther
Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Low physical activity/fitness | Other | Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing. Receives: Other: High-fat meal |
| High physical activity/fitness | Other | Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing. Receives: Other: High-fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglycerides
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Measured: Baseline
Post HFM Triglycerides
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Measured: 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.
Measured: 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.
Measured: 4 hours
Fasting LDL
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Measured: Baseline
Post HFM LDL
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Measured: 4 hours
Fasting HDL
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Measured: Baseline
Post HFM HDL
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Measured: 4 hours
Fasting non-HDL
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Measured: Baseline
Post HFM non-HDL
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Measured: 4 hours
Fasting LDL/HDL ratio
Assessment of risk for heart disease.
Measured: Baseline
Post HFM LDL/HDL ratio
Assessment of risk for heart disease.
Measured: 4 hours
Fasting anti-inflammatory surface receptor expression
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Measured: Baseline
Post HFM anti-inflammatory surface receptor expression
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Measured: 4 hours
Fasting pro-inflammatory surface receptor expression
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Measured: Baseline
Post HFM pro-inflammatory surface receptor expression
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Measured: 4 hours
Fasting brachial artery flow-mediated dilation
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Measured: Baseline
Post HFM brachial artery flow-mediated dilation
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Measured: 5.5 hours
Fasting superficial artery flow-mediated dilation
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Measured: Baseline
Post HFM superficial artery flow-mediated dilation
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Measured: 5.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start17 Jun 2019
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Xi
- Responsible party
- Sponsor
- Investigators
- Robert L Franco, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958734
- Sponsor's protocol ID
- HM20015510-1
- Status last verified
- Apr 2022
- First submitted
- 17 May 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1
- ClinicalTrials.gov ID
- NCT03958734
- Acronym / sponsor ID
- HM20015510-1
- Conditions
- Cardiovascular Risk Factor, Lipemia
- Keywords
- Vascular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Sigma Xi
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low physical activity/fitness | Other | Other: High-fat mealParticipants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing. |
| High physical activity/fitness | Other | Other: High-fat mealParticipants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat mealParticipants 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, Low physical activity/fitness |
Primary outcome
Fasting triglycerides
Time frame: Baseline
Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
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.
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.
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.
Fasting LDL
Time frame: Baseline
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Post HFM LDL
Time frame: 4 hours
Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Fasting HDL
Time frame: Baseline
High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
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.
Fasting non-HDL
Time frame: Baseline
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Post HFM non-HDL
Time frame: 4 hours
Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Fasting LDL/HDL ratio
Time frame: Baseline
Assessment of risk for heart disease.
Post HFM LDL/HDL ratio
Time frame: 4 hours
Assessment of risk for heart disease.
Fasting anti-inflammatory surface receptor expression
Time frame: Baseline
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM anti-inflammatory surface receptor expression
Time frame: 4 hours
CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting pro-inflammatory surface receptor expression
Time frame: Baseline
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM pro-inflammatory surface receptor expression
Time frame: 4 hours
CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting brachial artery flow-mediated dilation
Time frame: Baseline
Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
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.
Fasting superficial artery flow-mediated dilation
Time frame: Baseline
Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Franco, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat meal in people with Cardiovascular Risk Factor and Lipemia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting triglycerides (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.