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Completed

NCT Number: NCT00846599

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

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.

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Key information

Conditions

HIV Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Risk Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 study meal

Other

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

Saturated fat study meal

Other

Participant will eat a study meal high in saturated fat.

Primary outcomes

  1. To measure flow-mediated dilation before and after eating the two study meals.

    Time frame: Study visit 1 and 2

Secondary outcomes

  1. To compare the effect of different dietary fats on endothelial function.

    Time frame: Study visit 1 and 2

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Acronym: PERTH

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2009
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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