NCT02610374

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

October 23, 2015

Last Update Submit

January 6, 2022

Conditions

HIV

Keywords

Gut microbiota composition

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Cohort A

OTHER

HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.

Other: Agrarian DietOther: 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.

Other: Agrarian DietOther: 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.

Other: Agrarian DietOther: Western-type Diet

Interventions

Agrarian DietOTHER

A diet higher in carbohydrates and lower in fats and sugars

Cohort ACohort BCohort C
Western-type DietOTHER

A diet higher in fats and lower in carbohydrates

Cohort ACohort BCohort C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 41294355DERIVED

Study Officials

  • Catherine Lozupone, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

November 20, 2015

Study Start

March 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

US(1)