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

HIV Infections Clinical Trial

— PERTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846599
• Other study ID #: SUB730
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: October 11, 2017
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiovascular Risk
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection

Intervention

Other:
• Omega-3 study meal
Participant will eat a study meal high in omega-3 fatty acids.
• Saturated fat study meal
Participant will eat a study meal high in saturated fat.

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure flow-mediated dilation before and after eating the two study meals.		Study visit 1 and 2
Secondary	To compare the effect of different dietary fats on endothelial function.		Study visit 1 and 2

External Links

•   PERTH Study