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

Study Overview
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Brief Summary
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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.

Detailed Description
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Suboptimal cardiometabolic health is on a disproportional rise in Low- and Middle-Income Countries (LMICs). In sub-Saharan Africa (SSA), cardiometabolic dysfunction is being exacerbated by the ongoing nutrition transition, that has seen a change from traditional diets to fast and ultra processed foods rich in sugar, fats, and salt coupled by low physical activity (Kiyimba et al., 2022). Similarly, chronic inflammatory diseases such as HIV can aggravate cardiometabolic risks (Todowedo et al., 2019). Beyond conventional nutrients, fruits and vegetables have ubiquitous amounts of bioactive components including polyphenols, alkaloids, saponins, and terpenes and terpenoids, with polyphenols being the most ubiquitous of all. Dietary polyphenols are a diverse category of secondary plant metabolites that represent the largest group of naturally occurring antioxidants with cardioprotective benefits (Rijha et al., 2022 and Quero et al., 2020). Our recent inventory study of Uganda's IFV with purported cardiometabolic benefits, highlighted the popularity of Tamarindus indica as a local adjuvant therapy for cardiometabolic risks among Ugandan communities (Kiyimba et al., 2023). T. indica, is a leguminous tree belonging to the family Fabaceae with a wide range of bioactive constituents in varying levels- the highest being polyphenols followed by alkaloids, saponins, and terpenoids in that order (Luca et al., 2019 and Penev et al., 2016). Therefore, the aim of this trial is to evaluate the efficacy of T. indica fruit juice (added to patients' usual diets) on selected cardiometabolic risk markers of PLWH under the community-based HIV care model in Uganda in a proof-of-concept clinical trial. Two blinded juice prototypes of 10% and 30% fruit pulp packaged in amber bottles each consisting of 300mls will be supplied by the Uganda Natural Chemotherapeutics Research Institute. This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios. The study participants will be randomly allocated to consume twice-daily 600 mL of either 10% or 30% pulp of T. indica fruit juice. Both participants and the study team will be blinded to the intervention materials. Measurements will be performed at three different timelines: Baseline, Week two of the study, and Endline (week four of the study). Compliance to the study protocol will be confirmed by weekly telephone inquiries, and by counting the returned empty juice bottles or unused study products at each follow-up visit. Participants will be asked to maintain their habitual dietary regimen. The two juice prototypes will be blinded by assigning a secret code to each of the intervention products. As such, blinding of the investigators and participants will be undertaken to ensure a double-blind intervention. Moreover, the statistical analyses of the main endpoints will be done before breaking the intervention product concealment.

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

Conditions
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Cardiometabolic Syndrome, Dyslipidemias, Hypertension

Intervention / Treatment
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* Dietary Supplement: Tamarindus indica fruit juice_A
* Dietary Supplement: Tamarindus indica fruit juice_B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Taking dietary supplements TB co-infection, renal failure disease, liver cirrhosis, chronic pancreatitis Pregnancy and Lactation or regular sport activity Parallel participation in another clinical trial On treatment for; dyslipidemia, hypertension or diabetes and oral hypoglycemic drugs Very low blood pressure (< 90/50 mmHg) Not willing to consent or unable to consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios (1:1)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10% Tamarindus indica fruit pulp juice<br>Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 10% Tamarindus indica fruit pulp for 30 days | Dietary Supplement: Tamarindus indica fruit juice_A<br>* The participants will be exposed to 10% Tamarind pulp juice<br>|
| Experimental: 30% Tamarindus indica fruit pulp juice<br>Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 30% Tamarindus indica fruit pulp for 30 days | Dietary Supplement: Tamarindus indica fruit juice_B<br>* The participants will be exposed to 30% Tamarind pulp juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the concentrations of Triglycerides | A 10 mg/dL reduction in plasma triglycerides | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the concentrations of Total cholesterol | Reduction in plasma cholesterol | 30 days | 
| Changes in the concentrations of LDL-c | Reduction in plasma LDL-c | 30 days | 
| Changes in the concentration of HDL-c | increase in plasma HDL-c | 30 days | 
| Changes in the concentrations of Fasting Blood Glucose (FBG) | Reduction in FBG | 30 days | 
| Changes in Pulse wave velocity (m/s) | Measure of arterial stiffness (improvement in vascular function) | 30 days | 
| Changes in mmHg of Blood pressure | Improvement in both systolic and diastolic blood pressure | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular function, Tamarindus indica, Lipid metabolism, Glucose metabolism, Polyphenols, HIV