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

NCT ID: NCT03958734

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2021-04-29

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.

Conditions

Cardiovascular Risk Factor; Lipemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low physical activity/fitness

Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.

Group Type: OTHER

High-fat meal

Intervention Type: OTHER

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.

Group Type: OTHER

High-fat meal

Intervention Type: OTHER

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

Interventions

High-fat meal

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sigma Xi

UNKNOWN

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L Franco, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20015510-1

Identifier Type: -

Identifier Source: org_study_id