Cardiometabolic SyndromeNCT06058845
Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV
A study testing Tamarindus indica fruit juice_A and Tamarindus indica fruit juice_B in people with Cardiometabolic Syndrome and Dyslipidemias, run by KU Leuven at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cardiometabolic Syndrome, Dyslipidemias, Hypertension
- What is being tested?
- Tamarindus indica fruit juice_A and Tamarindus indica fruit juice_B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUganda
- Study dates
- 1 Oct 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- 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.
- Conditions
- Cardiometabolic Syndrome, Dyslipidemias, Hypertension
- Being tested
- Tamarindus indica fruit juice_A, Tamarindus indica fruit juice_B
- Keywords
- Vascular function, Tamarindus indica, Lipid metabolism, Glucose metabolism, Polyphenols, HIV
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamarindus indica fruit juice_ADietary supplement
The participants will be exposed to 10% Tamarind pulp juice
Tamarindus indica fruit juice_BDietary supplement
The participants will be exposed to 30% Tamarind pulp juice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Tamarindus indica fruit juice_B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the concentrations of Triglycerides
A 10 mg/dL reduction in plasma triglycerides
Measured: 30 days
Secondary outcomes (6)
Changes in the concentrations of Total cholesterol
Reduction in plasma cholesterol
Measured: 30 days
Changes in the concentrations of LDL-c
Reduction in plasma LDL-c
Measured: 30 days
Changes in the concentration of HDL-c
increase in plasma HDL-c
Measured: 30 days
Changes in the concentrations of Fasting Blood Glucose (FBG)
Reduction in FBG
Measured: 30 days
Changes in Pulse wave velocity (m/s)
Measure of arterial stiffness (improvement in vascular function)
Measured: 30 days
Changes in mmHg of Blood pressure
Improvement in both systolic and diastolic blood pressure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023
- Primary completion25 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios (1:1)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Mildmay Uganda Limited
- Responsible party
- Principal investigator, Christophe Matthys, KU Leuven
- Investigators
- Christophe Matthys, PhD, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058845
- Sponsor's protocol ID
- Tamarind_001
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 30606249Kiyimba 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.
PubMed 36034927Rajha 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.
PubMed 34806294Quero 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.
PubMed 32134090Luca 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.
PubMed 30614249Penev 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.
PubMed 26877662
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV and Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT06058845
- Acronym / sponsor ID
- Tamarind_001
- Conditions
- Cardiometabolic Syndrome, Dyslipidemias, Hypertension
- Keywords
- Vascular function, Tamarindus indica, Lipid metabolism, Glucose metabolism, Polyphenols, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Mildmay Uganda Limited
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a single centre, 2-arm, 4 weeks randomised, double-blinded parallel trial with equal allocation ratios (1:1)
| Arm | Type | Receives |
|---|---|---|
| 10% Tamarindus indica fruit pulp juice | Active comparator | Dietary Supplement: Tamarindus indica fruit juice_AParticipants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 10% Tamarindus indica fruit pulp for 30 days |
| 30% Tamarindus indica fruit pulp juice | Experimental | Dietary Supplement: Tamarindus indica fruit juice_BParticipants will follow a daily consumption of 600ml of Tamarindus indica fruit juice containing 30% Tamarindus indica fruit pulp for 30 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamarindus indica fruit juice_AThe participants will be exposed to 10% Tamarind pulp juice | Dietary supplement | 10% Tamarindus indica fruit pulp juice |
| Tamarindus indica fruit juice_BThe participants will be exposed to 30% Tamarind pulp juice | Dietary supplement | 30% Tamarindus indica fruit pulp juice |
Primary outcome
Changes in the concentrations of Triglycerides
Time frame: 30 days
A 10 mg/dL reduction in plasma triglycerides
6 secondary outcomes
Changes in the concentrations of Total cholesterol
Time frame: 30 days
Changes in the concentrations of LDL-c
Time frame: 30 days
Changes in the concentration of HDL-c
Time frame: 30 days
Changes in the concentrations of Fasting Blood Glucose (FBG)
Time frame: 30 days
Changes in Pulse wave velocity (m/s)
Time frame: 30 days
Changes in mmHg of Blood pressure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 30606249Todowede 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.
- Background: PubMed 36034927Kiyimba 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.
- Background: PubMed 34806294Rajha 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.
- Background: PubMed 32134090Quero 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.
- Background: PubMed 30614249Luca 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.
- Background: PubMed 26877662Penev 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Matthys, PhD study director
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamarindus indica fruit juice_A and Tamarindus indica fruit juice_B in people with Cardiometabolic Syndrome and Dyslipidemias, run by KU Leuven at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the concentrations of Triglycerides (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058845, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.