Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

Completed

• Conditions: HIV Infection; HIV Infections; Cardiovascular Risk
• Interventions: Other: Omega-3 study meal; Other: Saturated fat study meal

• Registration Number: NCT00846599
• Lead Sponsor: Tufts University

Brief Summary

The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.

Detailed Description

This study requires two visits. Once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. The participant will receive the other study meal during the second visit. At each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. The sample size is 50 subjects. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• HIV-positive white male aged >18 years

• Under one of the following treatment categories:

  • Treatment naive or have never taken any HIV medications
  • Taking Kaletra
  • Taking Sustiva
  • Taking Atripla

Exclusion Criteria

• Smoker

• Pre-existing diagnosis or treatment for the following:

  • Lipid disorder
  • Cardiovascular disease
  • High blood pressure
  • Diabetes

• Acute opportunistic infection or malignancy within last 3 months or current therapy for either

• Active IV drug use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Omega-3 study meal	High omega-3
2	Saturated fat study meal	High saturated fat

Primary Outcome Measures

Name	Time	Method
To measure flow-mediated dilation before and after eating the two study meals.	Study visit 1 and 2

Secondary Outcome Measures

Name	Time	Method
To compare the effect of different dietary fats on endothelial function.	Study visit 1 and 2

Trial Locations

Locations (1)

Tufts University; 🇺🇸 Boston, Massachusetts, United States