Clinical trial NCT03958734: Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Official title: Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lipemia
Keywords: Vascular Dysfunction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Sigma Xi
First posted: 2019-05-22
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Fasting triglycerides
timeFrame: Baseline
measure: Post HFM Triglycerides
timeFrame: 4 hours
measure: Fasting total cholesterol
timeFrame: Baseline
measure: Post HFM total cholesterol
timeFrame: 4 hours
measure: Fasting LDL
timeFrame: Baseline
measure: Post HFM LDL
timeFrame: 4 hours
measure: Fasting HDL
timeFrame: Baseline
measure: Post HFM HDL
timeFrame: 4 hours
measure: Fasting non-HDL
timeFrame: Baseline
measure: Post HFM non-HDL
timeFrame: 4 hours
measure: Fasting LDL/HDL ratio
timeFrame: Baseline
measure: Post HFM LDL/HDL ratio
timeFrame: 4 hours
measure: Fasting anti-inflammatory surface receptor expression
timeFrame: Baseline
measure: Post HFM anti-inflammatory surface receptor expression
timeFrame: 4 hours
measure: Fasting pro-inflammatory surface receptor expression
timeFrame: Baseline
measure: Post HFM pro-inflammatory surface receptor expression
timeFrame: 4 hours
measure: Fasting brachial artery flow-mediated dilation
timeFrame: Baseline
measure: Post HFM brachial artery flow-mediated dilation
timeFrame: 5.5 hours
measure: Fasting superficial artery flow-mediated dilation
timeFrame: Baseline
measure: Post HFM superficial artery flow-mediated dilation
timeFrame: 5.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Robert L Franco, PhD
role: PRINCIPAL_INVESTIGATOR
References: