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NCT06058845Completed

Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV

Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV and Elevated Triglycerides

Source: ClinicalTrials.gov · Last updated 15 Mar 2024

Brief summary (registry, in English)

The increasing burden of metabolic disturbances among People Living with HIV especially in developing countries has posed need for scientifically-proven, innovative, sustainable and cost-effective local adjuvant remedies to supplement conventional medical interventions. The goal of this clinical trial is to test the potential of Tamarindus indica fruit juice to improve cardiometabolic health of PLWH and elevated Triglycerides (TG). The main aims it aims to answer are to; * evaluate the efficacy of T. indica fruit juice on selected markers of lipid and glucose metabolism, and vascular health. * investigate a possible dose-response relationship on cardiometabolic control following intake of varying concentrations (fruit pulp percentages) of T. indica fruit juice. Participants will be required to consume 600 ml of either 10% or 30% fruit pulp juice a day for 30 days. From the baseline measurements, participants will be asked to comeback for repeat measurements after 14 days and finally on the 3oth day (Endline). Researchers will compare the groups that will be expose to the two juice prototypes to determine potential differences in TG levels.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
22 Sept 2023
Start date
1 Oct 2023
Primary completion date
25 Jan 2024
Lead sponsor
KU Leuven
NCT number
NCT06058845

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 1 Oct 2023 to the primary completion date, 25 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • TB co-infection, renal failure disease, liver cirrhosis, chronic pancreatitis
  • On treatment for; dyslipidemia, hypertension or diabetes and oral hypoglycemic drugs

Other

  • Taking dietary supplements
  • Pregnancy and Lactation or regular sport activity
  • Parallel participation in another clinical trial
  • Very low blood pressure (\< 90/50 mmHg)
  • Not willing to consent or unable to consent

Who the study is looking for

  • Triglycerides ≥150 mg/dL
  • TLD regimen (ART) for ≥12 months
  • 95% ART adherence in last 6 months
  • Virally suppressed (most recent results viral load suppressed within the last 12 months)
  • PLWH aged ≥30≤60 years.
  • No plans to change location in the next 6 months

Age in the registry: 30 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kajjansi HCIV
Coordinator of this site? Confirm its status
WakisoUgandaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.