Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agrarian Diet | Other | A diet higher in carbohydrates and lower in fats and sugars |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
HIV-infected cohort (Cohort A)
HIV-negative cohorts (Cohort B and C)
All Cohorts
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Lozupone, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41294355 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Western-type Diet | Other | A diet higher in fats and lower in carbohydrates |
|