HIV InfectionPERTHNCT00846599
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
An observational study of HIV Infection and Cardiovascular Risk, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Cardiovascular Risk, HIV Infections
- What is being tested?
- Omega-3 study meal and Saturated fat study meal
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infection, Cardiovascular Risk, HIV Infections
- Being tested
- Omega-3 study meal, Saturated fat study meal
- Keywords
- brachial artery ultrasound, brachial artery reactivity, HIV, human immunodeficiency virus, cardiovascular risk, omega three, saturated fat, sustiva, atripla, kaletra, treatment naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 study mealOther
Participant will eat a study meal high in omega-3 fatty acids.
Saturated fat study mealOther
Participant will eat a study meal high in saturated fat.
| Study group | Role | What they receive |
|---|---|---|
| 1 | High omega-3 Receives: Other: Omega-3 study meal | |
| 2 | High saturated fat Receives: Other: Saturated fat study meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure flow-mediated dilation before and after eating the two study meals.
Measured: Study visit 1 and 2
Secondary outcomes (1)
To compare the effect of different dietary fats on endothelial function.
Measured: Study visit 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Investigators
- Alexandra Mangili, MD, MPH, Principal investigator, Tufts University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846599
- Sponsor's protocol ID
- SUB730
- Acronym
- PERTH
- Status last verified
- Oct 2017
- First submitted
- 17 Feb 2009
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
- ClinicalTrials.gov ID
- NCT00846599
- Acronym / sponsor ID
- PERTH / SUB730
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Omega-3 study mealHigh omega-3 |
| 2 | – | Other: Saturated fat study mealHigh saturated fat |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.
Key inclusion criteria (6 listed)
- HIV-positive white male aged >18 years
- Under one of the following treatment categories:
Key exclusion criteria (8 listed)
- Smoker
- Pre-existing diagnosis or treatment for the following:
- Acute opportunistic infection or malignancy within last 3 months or current therapy for either
- Active IV drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 study mealParticipant will eat a study meal high in omega-3 fatty acids. | Other | 1 |
| Saturated fat study mealParticipant will eat a study meal high in saturated fat. | Other | 2 |
Primary outcome
To measure flow-mediated dilation before and after eating the two study meals.
Time frame: Study visit 1 and 2
1 secondary outcome
To compare the effect of different dietary fats on endothelial function.
Time frame: Study visit 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- PERTH StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Mangili, MD, MPH principal investigator
Tufts University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Cardiovascular Risk, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure flow-mediated dilation before and after eating the two study meals. (time frame: Study visit 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.