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

NCT00846599 | Completed

• 1 other identifier: SUB730
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Cardiovascular Risk; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Study visit 1 and 2

Secondary Outcomes (1)

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

  Study visit 1 and 2

Study Arms (2)

1

High omega-3

Other: Omega-3 study meal

2

High saturated fat

Other: Saturated fat study meal

Interventions

Omega-3 study meal OTHER

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

1

Saturated fat study meal OTHER

Participant will eat a study meal high in saturated fat.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Links

• PERTH Study

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Alexandra Mangili, MD, MPH

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

US (1)