Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients

February 3, 2022 updated by: Sunshine Specialty Health Care
Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more.
  • BMI increase of 10% or more since initiation of HIV treatment over a year period.
  • BMI equal to or greater than 30.
  • 18-85 years of age.

Exclusion Criteria:

  • Cancer
  • Pregnancy or breastfeeding
  • Intolerance to cruciferous vegetables
  • Intolerance to sulforaphane
  • Gluten Intolerance
  • Creatinine > 1.3 mg/dL
  • GFR < 60
  • AST or ALT > 1.5 times upper limit of normal.
  • White cell count < 2000 cells per ml.
  • Hemoglobin < 10.5 g/dL.
  • Platelet count < 140,000 per ml.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Other: Placebo
Placebo
Experimental: Sulforaphane Group
Drug: Sulforaphane
40 mg of Sulforaphane powder once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipids
Time Frame: 4 months
Triglycerides, Cholesterol
4 months
Inflammatory Markers
Time Frame: 4 months
CRP
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Specialty Health Care

Investigators

  • Principal Investigator: Jose A. Giron, MD, Sunshine Specialty Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 21, 2022

Primary Completion (Anticipated)

July 21, 2022

Study Completion (Anticipated)

September 21, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSHC1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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