HIVNCT02610374
Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
A study testing Agrarian Diet and Western-type Diet in people with HIV, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Agrarian Diet and Western-type Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infected cohort (Cohort A)
- Documentation of HIV-1 infection defined as a positive antibody test or plasma HIV-1 RNA (ribosomal ribonucleic acid).
- Treated with ART (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months
- Plasma HIV-1 RNA ≤ 50 copies/mL in the preceding 6 months.
- HIV-negative cohorts (Cohort B and C)
- Documentation of a negative HIV-1 antibody test
Show all 11Show fewer
- All Cohorts
- Age 18 to 65 years
- Body mass index between 21-29 kg/m2 (non-obese)
- Stable weight for at least 3 months (≤15% change in body weight)
- Negative pregnancy test (if female)
Who cannot join
- Use of systemic (oral or parenteral) antibiotics within two months prior to study entry
- Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.
Read the detailed description
This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.
- Conditions
- HIV
- Being tested
- Agrarian Diet, Western-type Diet
- Keywords
- Gut microbiota composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agrarian DietOther
A diet higher in carbohydrates and lower in fats and sugars
Western-type DietOther
A diet higher in fats and lower in carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Receives: Other: Agrarian Diet; Other: Western-type Diet |
| Cohort B | Other | HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Receives: Other: Agrarian Diet; Other: Western-type Diet |
| Cohort C | Other | HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Receives: Other: Agrarian Diet; Other: Western-type Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma IL-6 concentration (All Participants)
- The change in plasma IL-6 from baseline to week 4 for all participants (Cohorts A, B \& C) assigned to the Agrarian diet group will be compared to participants assigned to the Western diet group.
Measured: 4 weeks
Change in plasma IL-6 concentration (HIV-Infected Participants)
- The change in plasma IL-6 from baseline to week 4 for HIV-infected participants (Cohort A) assigned to an Agrarian diet will be compared to HIV-uninfected participants (Cohort B \& C) assigned to an Agrarian diet.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Lozupone, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610374
- Sponsor's protocol ID
- 15-1692
- Status last verified
- Jan 2022
- First submitted
- 23 Oct 2015
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Connor JB, Fouquier J, Neff CP, Sterrett JD, Marden T, Fiorillo S, Siebert JC, Schneider J, Nusbacher N, Noe AT, Fennimore B, Higgins J, Campbell TB, Palmer BE, Lozupone C. Agrarian diet improves metabolic health in HIV-positive men with Prevotella-rich microbiomes: results from a randomized trial. mSystems. 2025 Dec 17;10(12):e0118525. doi: 10.1128/msystems.01185-25. Epub 2025 Nov 26.
PubMed 41294355
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
- ClinicalTrials.gov ID
- NCT02610374
- Acronym / sponsor ID
- 15-1692
- Conditions
- HIV
- Keywords
- Gut microbiota composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 20 Nov 2015 (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 primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.
Detailed description
This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Other: Agrarian Diet, Other: Western-type DietHIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. |
| Cohort B | Other | Other: Agrarian Diet, Other: Western-type DietHIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. |
| Cohort C | Other | Other: Agrarian Diet, Other: Western-type DietHIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV-infected cohort (Cohort A)
- HIV-negative cohorts (Cohort B and C)
- All Cohorts
Key exclusion criteria (2 listed)
- Use of systemic (oral or parenteral) antibiotics within two months prior to study entry
- Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.
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 |
|---|---|---|
| Agrarian DietA diet higher in carbohydrates and lower in fats and sugars | Other | Cohort A, Cohort B, Cohort C |
| Western-type DietA diet higher in fats and lower in carbohydrates | Other | Cohort A, Cohort B, Cohort C |
Primary outcome
Change in plasma IL-6 concentration (All Participants)
Time frame: 4 weeks
- The change in plasma IL-6 from baseline to week 4 for all participants (Cohorts A, B \& C) assigned to the Agrarian diet group will be compared to participants assigned to the Western diet group.
Change in plasma IL-6 concentration (HIV-Infected Participants)
Time frame: 4 weeks
- The change in plasma IL-6 from baseline to week 4 for HIV-infected participants (Cohort A) assigned to an Agrarian diet will be compared to HIV-uninfected participants (Cohort B \& C) assigned to an Agrarian diet.
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 21 Jan 2022.
- Derived from this study: PubMed 41294355O'Connor JB, Fouquier J, Neff CP, Sterrett JD, Marden T, Fiorillo S, Siebert JC, Schneider J, Nusbacher N, Noe AT, Fennimore B, Higgins J, Campbell TB, Palmer BE, Lozupone C. Agrarian diet improves metabolic health in HIV-positive men with Prevotella-rich microbiomes: results from a randomized trial. mSystems. 2025 Dec 17;10(12):e0118525. doi: 10.1128/msystems.01185-25. Epub 2025 Nov 26.
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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.
Catherine Lozupone, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agrarian Diet and Western-type Diet in people with HIV, run by University of Colorado, Denver 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 11 inclusion and 2 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 21 Jan 2022. 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?
Change in plasma IL-6 concentration (All Participants) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610374, which also lists 1 linked publication.
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 Jan 2022.