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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03958734
Enrollment
59
Registered
2019-05-22
Start date
2019-06-17
Completion date
2021-04-29
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Lipemia

Keywords

Vascular Dysfunction

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.

Interventions

Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes

Sponsors

Sigma Xi
CollaboratorUNKNOWN
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fasting triglyceridesBaselineEster derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Post HFM Triglycerides4 hoursEster derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.
Fasting total cholesterolBaselineType 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 cholesterol4 hoursType 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 LDLBaselineLow density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Post HFM LDL4 hoursLow density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.
Fasting HDLBaselineHigh density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Post HFM HDL4 hoursHigh density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.
Fasting non-HDLBaselineTotal cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Post HFM non-HDL4 hoursTotal cholesterol minus HDL, often associated with a better assessment of risk for heart disease.
Fasting LDL/HDL ratioBaselineAssessment of risk for heart disease.
Post HFM LDL/HDL ratio4 hoursAssessment of risk for heart disease.
Fasting anti-inflammatory surface receptor expressionBaselineCD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM anti-inflammatory surface receptor expression4 hoursCD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting pro-inflammatory surface receptor expressionBaselineCD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Post HFM pro-inflammatory surface receptor expression4 hoursCD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.
Fasting brachial artery flow-mediated dilationBaselineDilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Post HFM brachial artery flow-mediated dilation5.5 hoursDilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Fasting superficial artery flow-mediated dilationBaselineDilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.
Post HFM superficial artery flow-mediated dilation5.5 hoursDilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026