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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Lipemia
Cardiovascular Risk Factor

Treatments

Other: High-fat meal

Study type

Interventional

Funder types

Other

Identifiers

NCT03958734
HM20015510-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

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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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Low physical activity/fitness
Other group
Description:
Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.
Treatment:
Other: High-fat meal
High physical activity/fitness
Other group
Description:
Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.
Treatment:
Other: High-fat meal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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