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Completed

NCT Number: NCT03958734

Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - 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.

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Key information

Conditions

Cardiovascular Risk Factor Dyslipidemias Hyperlipidemias Lipemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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

Treatment and study plan

High-fat Meal

Other

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

Primary outcomes

  1. Fasting triglycerides

    Time frame: Baseline

    Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.

  2. 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.

  3. 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.

  4. 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.

  5. Fasting LDL

    Time frame: Baseline

    Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.

  6. Post HFM LDL

    Time frame: 4 hours

    Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.

  7. Fasting HDL

    Time frame: Baseline

    High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.

  8. 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.

  9. Fasting non-HDL

    Time frame: Baseline

    Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.

  10. Post HFM non-HDL

    Time frame: 4 hours

    Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.

  11. Fasting LDL/HDL ratio

    Time frame: Baseline

    Assessment of risk for heart disease.

  12. Post HFM LDL/HDL ratio

    Time frame: 4 hours

    Assessment of risk for heart disease.

  13. Fasting anti-inflammatory surface receptor expression

    Time frame: Baseline

    CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  14. Post HFM anti-inflammatory surface receptor expression

    Time frame: 4 hours

    CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  15. Fasting pro-inflammatory surface receptor expression

    Time frame: Baseline

    CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  16. Post HFM pro-inflammatory surface receptor expression

    Time frame: 4 hours

    CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.

  17. Fasting brachial artery flow-mediated dilation

    Time frame: Baseline

    Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  18. 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.

  19. Fasting superficial artery flow-mediated dilation

    Time frame: Baseline

    Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.

  20. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Sigma Xi

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 22, 2019
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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