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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846599
First Posted: February 18, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tufts University
February 17, 2009
February 18, 2009
October 12, 2017
January 2008
January 2010   (Final data collection date for primary outcome measure)
To measure flow-mediated dilation before and after eating the two study meals. [ Time Frame: Study visit 1 and 2 ]
Same as current
Complete list of historical versions of study NCT00846599 on ClinicalTrials.gov Archive Site
To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ]
Same as current
Not Provided
Not Provided
 
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.
  • HIV Infection
  • Cardiovascular Risk
  • HIV Infections
  • Other: Omega-3 study meal
    Participant will eat a study meal high in omega-3 fatty acids.
  • Other: Saturated fat study meal
    Participant will eat a study meal high in saturated fat.
  • 1
    High omega-3
    Intervention: Other: Omega-3 study meal
  • 2
    High saturated fat
    Intervention: Other: Saturated fat study meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00846599
SUB730
No
Not Provided
Not Provided
Alexandra Mangili, MD, MPH, Tufts University School of Medicine
Tufts University
Not Provided
Principal Investigator: Alexandra Mangili, MD, MPH Tufts University School of Medicine
Tufts University
October 2017