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

Primary Purpose

Cardiometabolic Syndrome, Dyslipidemias, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Tamarindus indica fruit juice_A
Tamarindus indica fruit juice_B
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiometabolic Syndrome focused on measuring Vascular function, Tamarindus indica, Lipid metabolism, Glucose metabolism, Polyphenols, HIV

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kajjansi HCIVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

10% Tamarindus indica fruit pulp juice

30% Tamarindus indica fruit pulp juice

Arm Description

Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 10% Tamarindus indica fruit pulp for 30 days

Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 30% Tamarindus indica fruit pulp for 30 days

Outcomes

Primary Outcome Measures

Changes in the concentrations of Triglycerides
A 10 mg/dL reduction in plasma triglycerides

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2023
Last Updated
October 6, 2023
Sponsor
KU Leuven
Collaborators
Mildmay Uganda Limited
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1. Study Identification

Unique Protocol Identification Number
NCT06058845
Brief Title
Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV
Official Title
Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV and Elevated Triglycerides
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Mildmay Uganda Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome, Dyslipidemias, Hypertension
Keywords
Vascular function, Tamarindus indica, Lipid metabolism, Glucose metabolism, Polyphenols, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios (1:1)
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10% Tamarindus indica fruit pulp juice
Arm Type
Active Comparator
Arm Description
Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 10% Tamarindus indica fruit pulp for 30 days
Arm Title
30% Tamarindus indica fruit pulp juice
Arm Type
Experimental
Arm Description
Participants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 30% Tamarindus indica fruit pulp for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Tamarindus indica fruit juice_A
Intervention Description
The participants will be exposed to 10% Tamarind pulp juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Tamarindus indica fruit juice_B
Intervention Description
The participants will be exposed to 30% Tamarind pulp juice
Primary Outcome Measure Information:
Title
Changes in the concentrations of Triglycerides
Description
A 10 mg/dL reduction in plasma triglycerides
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Changes in the concentrations of Total cholesterol
Description
Reduction in plasma cholesterol
Time Frame
30 days
Title
Changes in the concentrations of LDL-c
Description
Reduction in plasma LDL-c
Time Frame
30 days
Title
Changes in the concentration of HDL-c
Description
increase in plasma HDL-c
Time Frame
30 days
Title
Changes in the concentrations of Fasting Blood Glucose (FBG)
Description
Reduction in FBG
Time Frame
30 days
Title
Changes in Pulse wave velocity (m/s)
Description
Measure of arterial stiffness (improvement in vascular function)
Time Frame
30 days
Title
Changes in mmHg of Blood pressure
Description
Improvement in both systolic and diastolic blood pressure
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Changes in Waist circumference (WC)
Description
Reduction in WC
Time Frame
30 days
Title
Changes in Kg of body's fat mass
Description
Improvement in fat mass (reduction)
Time Frame
30 days
Title
Changes in Body weight
Description
reduction in body weight
Time Frame
30 days
Title
Changes in BMI
Description
reduction in BMI
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tonny Kiyimba, MSc
Phone
+32466284813
Email
tonny.kiyimba1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Ogwok, PhD
Phone
+256772647968
Email
ogwokp@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Matthys, PhD
Organizational Affiliation
KU Leuven
Official's Role
Study Director
Facility Information:
Facility Name
Kajjansi HCIV
City
Wakiso
ZIP/Postal Code
256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fred Kigozi, MSc
Phone
+256701530822
Email
kigsfred@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tonny Kiyimba, MSc
First Name & Middle Initial & Last Name & Degree
Fred Kigozi, MSc
First Name & Middle Initial & Last Name & Degree
Michael Bamuwamye, PhD
First Name & Middle Initial & Last Name & Degree
Peter Yiga, PhD
First Name & Middle Initial & Last Name & Degree
Patrick Ogwok, PhD
First Name & Middle Initial & Last Name & Degree
Kathrine Nakatudde, BSc
First Name & Middle Initial & Last Name & Degree
Winnie Nabbanja, BSc
First Name & Middle Initial & Last Name & Degree
Bart Vanderschueren, PhD
First Name & Middle Initial & Last Name & Degree
Christophe Matthys, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30606249
Citation
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.
Results Reference
background
PubMed Identifier
36034927
Citation
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.
Results Reference
background
PubMed Identifier
34806294
Citation
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.
Results Reference
background
PubMed Identifier
32134090
Citation
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.
Results Reference
background
PubMed Identifier
30614249
Citation
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.
Results Reference
background
PubMed Identifier
26877662
Citation
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.
Results Reference
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Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV

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