Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02610374

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Other: Agrarian Diet Other: Western-type Diet	N/A

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

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Cohort A HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.	Other: Agrarian Diet A diet higher in carbohydrates and lower in fats and sugars Other: Western-type Diet A diet higher in fats and lower in carbohydrates
Other: Cohort B HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.	Other: Agrarian Diet A diet higher in carbohydrates and lower in fats and sugars Other: Western-type Diet A diet higher in fats and lower in carbohydrates
Other: Cohort C HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.	Other: Agrarian Diet A diet higher in carbohydrates and lower in fats and sugars Other: Western-type Diet A diet higher in fats and lower in carbohydrates

Arm

Intervention/Treatment

Other: Cohort A

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

Other: Agrarian Diet

A diet higher in carbohydrates and lower in fats and sugars

Other: Western-type Diet

A diet higher in fats and lower in carbohydrates

Other: Cohort B

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

Other: Agrarian Diet

A diet higher in carbohydrates and lower in fats and sugars

Other: Western-type Diet

A diet higher in fats and lower in carbohydrates

Other: Cohort C

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

Other: Agrarian Diet

A diet higher in carbohydrates and lower in fats and sugars

Other: Western-type Diet

A diet higher in fats and lower in carbohydrates

Outcome Measures

Primary Outcome Measures

Change in plasma IL-6 concentration (All Participants) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Catherine Lozupone, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02610374

Other Study ID Numbers:

15-1692

First Posted:

Nov 20, 2015

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Keywords provided by University of Colorado, Denver

Gut microbiota composition

Study Results

No Results Posted as of Jan 21, 2022