An interventional study of Sacha-Q10 Plus and Placebo in Cardiovascular Disease (CVD), Elevated Cardiovascular Risk and Endothelial Dysfunction, sponsored by Hospital Pengajar Universiti Putra Malaysia. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Hospital Pengajar Universiti Putra Malaysia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if Sacha Inchi-CoQ10 supplementation can improve cardiovascular health in adults who have an increased risk of cardiovascular disease. The study will also learn about the safety and tolerability of Sacha Inchi-CoQ10 supplementation.
The main questions it aims to answer are:
Does Sacha Inchi-CoQ10 supplementation improve cardiovascular function compared with placebo? Does Sacha Inchi-CoQ10 supplementation improve blood pressure, cholesterol, blood sugar, inflammation, and oxidative stress? Is Sacha Inchi-CoQ10 supplementation safe and well tolerated?
Researchers will compare Sacha Inchi-CoQ10 supplementation with a placebo (a look-alike supplement that does not contain Sacha Inchi-CoQ10) to see whether the supplementation improves cardiovascular health.
Participants will:
Take Sacha Inchi-CoQ10 supplementation or placebo for 12 weeks Visit the study clinic for screening, baseline, week 6, and week 12 assessments Have cardiovascular assessments, including echocardiography and blood pressure measurements Provide blood samples to assess cholesterol, blood sugar, inflammation, and oxidative stress Have their weight, body composition, and other health measurements assessed Complete questionnaires about their diet, physical activity, and quality of life Record their supplement intake and any symptoms or side effects during the study
This is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating Sacha-Q10 Plus, a combined Sacha Inchi and Coenzyme Q10 (CoQ10) supplementation, among adults with increased cardiovascular risk or stable cardiovascular disease. The study will be conducted at Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia, with participant recruitment carried out primarily through the Family Medicine Clinic.
Sacha Inchi (Plukenetia volubilis) is a natural source of essential fatty acids, particularly omega-3 fatty acids such as alpha-linolenic acid (ALA), as well as omega-6 and omega-9 fatty acids. Coenzyme Q10 is a mitochondrial antioxidant involved in cellular energy production and antioxidant defence. The combination is proposed to target multiple pathways involved in cardiovascular disease, including oxidative stress, inflammation, endothelial dysfunction, and cardiometabolic abnormalities.
Participants will be randomly assigned in a 1:1 ratio to receive either Sacha-Q10 Plus supplementation or a matching placebo. The intervention group will receive two softgels daily for 12 weeks. The intervention and placebo will be identical in appearance and packaging to maintain blinding among participants, investigators, and outcome assessors. Participants will be advised to maintain their usual diet and physical activity and to continue their prescribed medications without modification unless otherwise directed by their physician.
Study assessments will be conducted at screening, baseline (week 0), week 6, and week 12. Assessments will include clinical measurements, fasting blood sampling, blood pressure measurement, body composition assessment, and transthoracic echocardiography. Blood samples will be used to assess routine biochemical parameters, inflammatory biomarkers, and oxidative stress markers. Body composition will be assessed using bioelectrical impedance analysis, including phase angle measurement.
At the week 6 visit, participants will undergo interim safety and compliance monitoring, including assessment of adverse events, capsule counts, participant diaries, selected biochemical parameters, body composition, and blood pressure. At week 12, the baseline assessments will be repeated to evaluate changes following the intervention period. Dietary intake, physical activity, and health-related quality of life will also be assessed during the study period.
Compliance will be assessed through capsule counts and participant diaries. A compliance rate of at least 80% will be considered acceptable for inclusion in the per-protocol analysis. Safety and tolerability will be monitored throughout the study through active questioning, participant self-reporting, adverse event documentation, and clinical laboratory assessments, including renal and liver function tests. Adverse events will be documented according to their onset, duration, severity, frequency, outcome, and relationship to the study intervention. Serious adverse events will be reported and managed according to applicable institutional and regulatory requirements.
Data will be analysed according to the intention-to-treat principle, with per-protocol analysis conducted as a sensitivity analysis. Appropriate statistical methods will be used to compare outcomes between the intervention and placebo groups, including analysis of covariance for post-intervention comparisons and linear mixed-effects models or repeated measures analysis for outcomes assessed at multiple time points.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Hospital Pengajar Universiti Putra Malaysia is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hypertension; Dyslipidaemia; Controlled diabetes mellitus; or High cardiovascular risk, defined as Framingham Risk Score ≥10%.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive Sacha Inchi-CoQ10 softgel supplementation, 2 softgels daily for 12 weeks.
Dietary Supplement: Sacha-Q10 Plus
Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.
Dietary Supplement: Placebo
Participants assigned to the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks.
Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.
Change in Endothelial-Related Cardiovascular Function Assessed by Transthoracic Echocardiography from Baseline to 12 Weeks
Parameters measured in this outcome: * LV ventricular function (%) * Myocardial Performance Index (Tei Index) * Left Ventricular End-Diastolic Diameter (mm) * Septal thickness (mm) * Wall thickness (mm)
Time frame: Assessed at baseline and Week 12 of the 12-week intervention period.
Change from Baseline in Cardiometabolic, Inflammatory and Oxidative Stress Biomarkers, Body Composition, and Safety and Compliance Assessment at Week 12
Parameters measured: Cardiometabolic Markers: Blood Pressure (mmHg) Total Cholesterol (mmol/L) HbA1c (%) Inflammatory Biomarkers: High-Sensitivity C-Reactive Protein (hsCRP) (mg/L) Interleukin-6 (IL-6) (pg/mL) Tumor Necrosis Factor-Alpha (TNF-α) (pg/mL) Matrix Metalloproteinase-3 (MMP-3) (ng/mL) Oxidative Stress Biomarkers: Superoxide Dismutase (SOD) (U/mL) Glutathione Peroxidase (GPx) (U/mL) Catalase Activity (U/mL) Lipid Peroxidation (LPO) (nmol/mL) Anthropometry and Body Composition: BMI (kg/m²) Waist Circumference (cm) Body Composition (%) Safety: Number of Participants Experiencing Adverse Events Change From Baseline in Serum Creatinine at Week 12 (µmol/L) Change From Baseline in Liver Function Test Parameters at Week 12 ( U/L) Compliance: Percentage of Prescribed Study Capsules Consumed During the 12-Week Intervention Period (%)
Time frame: Baseline, Week 4, Week 8, and Week 12 of the 12-week intervention period.
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be made publicly available because the informed consent obtained from participants does not include permission for unrestricted data sharing.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 8 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital Pengajar Universiti Putra Malaysia