HivNCT03846206
Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV
A study testing mediterranean diet in people with Hiv, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2016to 1 Dec 2019
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years of age;
- To sign voluntary informed consent;
- Male or female patients with a negative pregnancy test before inclusion in the study;
- Proven HIV infection (with HIV-1 positive antibodies);
- Patient should be on stable treatment with cART for at least 1 year
- The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3
- The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;
- HIV viral load should be undetectable at least 6 months prior to study inclusion, and less determinations (occasional blips above the undetectable level are allowed).
Who cannot join
- Acquired Immunodeficiency Syndrome.
- Active opportunistic diseases.
- Patients coinfected with HCV or HBV
- Coagulopathy
- Renal insufficiency (creatinine> 1.5 mg / dL)
- Pregnancy or breastfeeding
Show all 14Show fewer
- Inability to sign informed consent
- Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
- Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;
- Use of anticoagulant medication;
- Use of any type of experimental medication during the 90 days prior to study entry;
- Uncontrolled psychiatric disorder;
- Patients with uncontrolled active autoimmune diseases;
- Usual use of antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Bacterial Translocation and Immune Activation in Patients Infected With HIV After Change to a Supplemented Mediterranean Diet: Two Arms Randomized Prospective Trial.
Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml.
Read the detailed description
Mediterranean diet supplemented by nuts and extra virgin olive oil has shown to reduce mortality, cardiovascular diseases, and breast cancer in HIV uninfected individuals. It is likely that changes in the microbiome could play a role in this effect. The goal of the study is to evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml. One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.
- Conditions
- Hiv
- Being tested
- mediterranean diet
- Keywords
- Microbiota., Mediterranean Diet, Bacterial Traslocation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean dietDietary supplement
a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months
| Study group | Role | What they receive |
|---|---|---|
| mediterranean diet | Experimental | Patients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months Receives: Dietary Supplement: mediterranean diet |
| Usual diet | No intervention | Patients do usual diet for three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in levels of sCD14 at baseline and month 3 between groups
parameters of bacterial translocation
Measured: 2 year
Secondary outcomes (6)
Changes in EndocAB and LBP levels at baseline and month 3 between groups.
other parameters of bacterial translocation.
Measured: 2 year
Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups
Microbioma
Measured: 2 years
Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups
inflammatory markers
Measured: 2 years
Changes in lipids at baseline and month 3 between groups
Lipids
Measured: 2 years
Changes in expression of CD38, HLA DR in CD4 and CD8 T cells at baseline and month 3 between groups
immune-activation markers
Measured: 2 years
Changes in total and integrated DNA
Marker of HIV reservoir
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Jul 2016
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- . One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Garcia, Hospital Clinic of Barcelona
- Investigators
- Felipe García, MD, PhD, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846206
- Sponsor's protocol ID
- Clinic Hospital of Barcelona
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bacterial Translocation and Immune Activation in Patients Infected With HIV After Change to a Supplemented Mediterranean Diet: Two Arms Randomized Prospective Trial.
- ClinicalTrials.gov ID
- NCT03846206
- Acronym / sponsor ID
- Clinic Hospital of Barcelona
- Conditions
- Hiv
- Keywords
- Microbiota., Mediterranean Diet, Bacterial Traslocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jul 2016
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 19 Feb 2019 (actual)
- 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.
Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml.
Detailed description
Mediterranean diet supplemented by nuts and extra virgin olive oil has shown to reduce mortality, cardiovascular diseases, and breast cancer in HIV uninfected individuals. It is likely that changes in the microbiome could play a role in this effect. The goal of the study is to evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4> 500cells/ml. One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- . One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.
| Arm | Type | Receives |
|---|---|---|
| mediterranean diet | Experimental | Dietary Supplement: mediterranean dietPatients do Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months |
| Usual diet | No intervention | –Patients do usual diet for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient ≥ 18 years of age;
- To sign voluntary informed consent;
- Male or female patients with a negative pregnancy test before inclusion in the study;
- Proven HIV infection (with HIV-1 positive antibodies);
- Patient should be on stable treatment with cART for at least 1 year
Key exclusion criteria (14 listed)
- Acquired Immunodeficiency Syndrome.
- Active opportunistic diseases.
- Patients coinfected with HCV or HBV
- Coagulopathy
- Renal insufficiency (creatinine> 1.5 mg / dL)
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 |
|---|---|---|
| mediterranean dieta Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months | Dietary supplement | mediterranean diet |
Primary outcome
Differences in levels of sCD14 at baseline and month 3 between groups
Time frame: 2 year
parameters of bacterial translocation
6 secondary outcomes
Changes in EndocAB and LBP levels at baseline and month 3 between groups.
Time frame: 2 year
Changes in microbiota (fecal 16s rRNA) at baseline and month 3 between groups
Time frame: 2 years
Changes in ultrasensitive PCR, TNF-alpha, IL-6 and Dimer-D at baseline and month 3 between groups
Time frame: 2 years
Changes in lipids at baseline and month 3 between groups
Time frame: 2 years
Changes in expression of CD38, HLA DR in CD4 and CD8 T cells at baseline and month 3 between groups
Time frame: 2 years
Changes in total and integrated DNA
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Felipe García, MD, PhD principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet in people with Hiv, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. 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 Spain. 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?
Results are not available in the source record.
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?
Differences in levels of sCD14 at baseline and month 3 between groups (time frame: 2 year). 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 21 Aug 2019.