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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00846599
Acronym
PERTH
Enrollment
50
Registered
2009-02-18
Start date
2008-01-31
Completion date
2010-01-31
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk, HIV Infection, HIV Infections

Keywords

brachial artery ultrasound, brachial artery reactivity, HIV, human immunodeficiency virus, cardiovascular risk, omega three, saturated fat, sustiva, atripla, kaletra, treatment naive

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.

Interventions

OTHEROmega-3 study meal

Participant will eat a study meal high in omega-3 fatty acids.

OTHERSaturated fat study meal

Participant will eat a study meal high in saturated fat.

Sponsors

Tufts University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To measure flow-mediated dilation before and after eating the two study meals.Study visit 1 and 2

Secondary

MeasureTime frame
To compare the effect of different dietary fats on endothelial function.Study visit 1 and 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026