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

NCT06058845 | Completed DMC

• 1 other identifier: Tamarind_001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiometabolic Syndrome; Dyslipidemias; Hypertension

Keywords

Vascular function; Tamarindus indica; Lipid metabolism; Glucose metabolism; Polyphenols; HIV

Outcome Measures

Primary Outcomes (1)

• Changes in the concentrations of Triglycerides

  A 10 mg/dL reduction in plasma triglycerides

  30 days

Secondary Outcomes (6)

• Changes in the concentrations of Total cholesterol

  30 days

• Changes in the concentrations of LDL-c

  30 days

• Changes in the concentration of HDL-c

  30 days

• Changes in the concentrations of Fasting Blood Glucose (FBG)

  30 days

• Changes in Pulse wave velocity (m/s)

  30 days

Other Outcomes (4)

• Changes in Waist circumference (WC)

  30 days

• Changes in Kg of body's fat mass

  30 days

• Changes in Body weight

  30 days

Study Arms (2)

10% Tamarindus indica fruit pulp juice

ACTIVE COMPARATOR

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

30% Tamarindus indica fruit pulp juice

EXPERIMENTAL

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

Interventions

Tamarindus indica fruit juice_A DIETARY_SUPPLEMENT

The participants will be exposed to 10% Tamarind pulp juice

10% Tamarindus indica fruit pulp juice

Tamarindus indica fruit juice_B DIETARY_SUPPLEMENT

The participants will be exposed to 30% Tamarind pulp juice

30% Tamarindus indica fruit pulp juice

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Triglycerides ≥150 mg/dL
• TLD regimen (ART) for ≥12 months
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Mildmay Uganda Limited: collaborator

Study Sites (1)

Kajjansi HCIV

Wakiso, 256, Uganda

Location

Related Publications (6)

• 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.

  PMID: 30606249 BACKGROUND

• 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.

  PMID: 36034927 BACKGROUND

• 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.

  PMID: 34806294 BACKGROUND

• 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.

  PMID: 32134090 BACKGROUND

• 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.

  PMID: 30614249 BACKGROUND

• 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.

  PMID: 26877662 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Dyslipidemias; Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christophe Matthys, PhD

  KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and the study team will be blinded to the intervention materials. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios (1:1)

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will become available from 9-36 months after the publication of the study-results by the research team.
• 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

Locations

UG (1)