Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958734
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Sigma Xi
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Lipemia Other: High-fat meal Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958734


Contacts
Layout table for location contacts
Contact: Robert L Franco, PhD 804-828-1948 francorl@vcu.edu
Contact: Lauren Pedersen, MS 804-828-1948 pedersenl@vcu.edu

Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Sigma Xi
Investigators
Layout table for investigator information
Principal Investigator: Robert L Franco, PhD Virginia Commonwealth University

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03958734     History of Changes
Other Study ID Numbers: HM20015510-1
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Vascular Dysfunction