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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Tufts University.
Recruitment status was  Recruiting
Information provided by:
Tufts University Identifier:
First received: February 17, 2009
Last updated: December 2, 2009
Last verified: December 2009
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.

Condition Intervention
HIV Infection
Cardiovascular Risk
HIV Infections
Other: Omega-3 study meal
Other: Saturated fat study meal

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

Resource links provided by NLM:

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • To measure flow-mediated dilation before and after eating the two study meals. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
High omega-3
Other: Omega-3 study meal
Participant will eat a study meal high in omega-3 fatty acids.
High saturated fat
Other: Saturated fat study meal
Participant will eat a study meal high in saturated fat.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00846599

Contact: Mari Imai 617-636-3496

United States, Massachusetts
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Alexandra Mangili, MD, MPH         
Sponsors and Collaborators
Tufts University
Principal Investigator: Alexandra Mangili, MD, MPH Tufts University School of Medicine
  More Information

Additional Information:
Responsible Party: Alexandra Mangili, MD, MPH, Tufts University School of Medicine Identifier: NCT00846599     History of Changes
Other Study ID Numbers: SUB730 
Study First Received: February 17, 2009
Last Updated: December 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
brachial artery ultrasound
brachial artery reactivity
human immunodeficiency virus
cardiovascular risk
omega three
saturated fat
treatment naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on May 26, 2016