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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias; Cardiometabolic Syndrome
• Intervention / Treatment: Dietary supplement: Tamarindus indica fruit juice_A; Dietary supplement: Tamarindus indica fruit juice_B

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tonny Kiyimba, MSc; Phone Number: +32466284813; Email: tonny.kiyimba1@gmail.com
• Study Contact Backup: Name: Patrick Ogwok, PhD; Phone Number: +256772647968; Email: ogwokp@yahoo.com

Study Locations

• Uganda
  • Wakiso, Uganda, 256
    • Kajjansi HCIV
    • Contact: Fred Kigozi, MSc; Phone Number: +256701530822; Email: kigsfred@yahoo.com
    • Principal Investigator: Tonny Kiyimba, MSc
    • Sub-Investigator: Fred Kigozi, MSc
    • Sub-Investigator: Michael Bamuwamye, PhD
    • Sub-Investigator: Peter Yiga, PhD
    • Sub-Investigator: Patrick Ogwok, PhD
    • Sub-Investigator: Kathrine Nakatudde, BSc
    • Sub-Investigator: Winnie Nabbanja, BSc
    • Sub-Investigator: Bart Vanderschueren, PhD
    • Sub-Investigator: Christophe Matthys, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10% Tamarindus indica fruit pulp juice; 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; The participants will be exposed to 10% Tamarind pulp juice
Experimental: 30% Tamarindus indica fruit pulp juice; 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; The participants will be exposed to 30% Tamarind pulp juice

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Waist circumference (WC)	Reduction in WC	30 days
Changes in Kg of body's fat mass	Improvement in fat mass (reduction)	30 days
Changes in Body weight	reduction in body weight	30 days
Changes in BMI	reduction in BMI	30 days

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Mildmay Uganda Limited
• Investigators: Study Director: Christophe Matthys, PhD, KU Leuven

Publications and helpful links

General Publications

• Luca SV, Macovei I, Bujor A, Miron A, Skalicka-Wozniak K, Aprotosoaie AC, Trifan A. Bioactivity of dietary polyphenols: The role of metabolites. Crit Rev Food Sci Nutr. 2020;60(4):626-659. doi: 10.1080/10408398.2018.1546669. Epub 2019 Jan 7.
• Todowede OO, Mianda SZ, Sartorius B. Prevalence of metabolic syndrome among HIV-positive and HIV-negative populations in sub-Saharan Africa-a systematic review and meta-analysis. Syst Rev. 2019 Jan 3;8(1):4. doi: 10.1186/s13643-018-0927-y.
• Kiyimba T, Kigozi F, Yiga P, Mukasa B, Ogwok P, Van der Schueren B, Matthys C. The cardiometabolic profile and related dietary intake of Ugandans living with HIV and AIDS. Front Nutr. 2022 Aug 11;9:976744. doi: 10.3389/fnut.2022.976744. eCollection 2022.
• Rajha HN, Paule A, Aragones G, Barbosa M, Caddeo C, Debs E, Dinkova R, Eckert GP, Fontana A, Gebrayel P, Maroun RG, Napolitano A, Panzella L, Pasinetti GM, Stevens JF, Schieber A, Edeas M. Recent Advances in Research on Polyphenols: Effects on Microbiota, Metabolism, and Health. Mol Nutr Food Res. 2022 Jan;66(1):e2100670. doi: 10.1002/mnfr.202100670. Epub 2021 Dec 2.
• Quero J, Marmol I, Cerrada E, Rodriguez-Yoldi MJ. Insight into the potential application of polyphenol-rich dietary intervention in degenerative disease management. Food Funct. 2020 Apr 30;11(4):2805-2825. doi: 10.1039/d0fo00216j.
• Penev L, Paton A, Nicolson N, Kirk P, Pyle RL, Whitton R, Georgiev T, Barker C, Hopkins C, Robert V, Biserkov J, Stoev P. A common registration-to-publication automated pipeline for nomenclatural acts for higher plants (International Plant Names Index, IPNI), fungi (Index Fungorum, MycoBank) and animals (ZooBank). Zookeys. 2016 Jan 7;(550):233-46. doi: 10.3897/zookeys.550.9551. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Polyphenols; Vascular function; Lipid metabolism; Glucose metabolism; Tamarindus indica
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: Tamarind_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

For all the data generated during the course of this study, we will follow the prevailing standards and guidelines in documenting and depositing data sets.

The research team will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. Regarding data sharing, International Committee of Medical Journal Editors recommendations will be followed.

Individual deidentified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after deidentification (text, tables, figures and appendices).

• IPD Sharing Time Frame: Data will become available from 9-36 months after the publication of the study-results by the research team.
• IPD Sharing Access Criteria: Data will only be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to Prof. Christophe Matthys (Christophe.matthys@uzleuven.be). To gain access, data requestors will need to sign a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No