Sacha Inchi-CoQ10 Supplementation and Cardiovascular Health (Sacha-Q10)

August 27, 2026 updated by: Hospital Pengajar Universiti Putra Malaysia

Effects of Sacha Inchi-CoQ10 Supplementation on Endothelial-related Cardiovascular Function, Cardiometabolic Risk Factors, and Inflammatory Biomarkers Among Adults at Increased Cardiovascular Risk: A Double-blind Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Prof. Dr. Chan Yoke Mun
  • Phone Number: +60 16-391 6589
  • Email: cym@upm.edu.my

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 40 to 75 years.
  • Male or female.
  • Have one or more cardiovascular risk factors or stable cardiovascular disease, including:

Hypertension; Dyslipidaemia; Controlled diabetes mellitus; or High cardiovascular risk, defined as Framingham Risk Score ≥10%.

  • Able to provide written informed consent.
  • Able and willing to comply with the study procedures and follow-up visits.

Exclusion Criteria:

  • Unstable cardiovascular disease.
  • Severe renal impairment.
  • Severe hepatic impairment.
  • Active malignancy.
  • Pregnant or lactating women.
  • Known allergy to any study components.
  • Current use of omega-3, Sacha Inchi oil or Coenzyme Q10 supplements within the past three months.
  • Participation in another clinical trial within the past three months.
  • Impaired decision-making capacity, including cognitive impairment or severe mental disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacha Inchi-CoQ10 supplementation Group
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 the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks.
Placebo Comparator: Placebo Group
Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.
Dietary supplement: Placebo
Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endothelial-Related Cardiovascular Function Assessed by Transthoracic Echocardiography from Baseline to 12 Weeks
Time Frame: Assessed at baseline and Week 12 of the 12-week intervention period.

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)
Assessed at baseline and Week 12 of the 12-week intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Cardiometabolic, Inflammatory and Oxidative Stress Biomarkers, Body Composition, and Safety and Compliance Assessment at Week 12
Time Frame: Baseline, Week 4, Week 8, and Week 12 of the 12-week intervention period.

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 (%)
Baseline, Week 4, Week 8, and Week 12 of the 12-week intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pengajar Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Stark BA, DeCleene NK, Desai EC, Hsu JM, Johnson CO, Lara-Castor L, et al. Global, Regional, and National Burden of Cardiovascular Diseases and Risk Factors in 204 Countries and Territories, 1990-2023. J Am Coll Cardiol. 2025 Dec 2;86(22):2167-243. doi:10.1016/J.JACC.2025.08.015 PubMed PMID: 40990886. Department of Statistics Malaysia [Internet]. [cited 2026 Apr 12]. Available from: https://www.dosm.gov.my/portal-main/release-content/statistics-on-causes-of-death-malaysia-2025 Wan KS, Mohd Yusoff MF, Mat Rifin H, Chan WK, Alias N, Tham SW, et al. Prevalence of high 10-year cardiovascular risk among the general population in Malaysia and the associated factors: a nationwide community-based study in 2023. BMC Public Health. 2025 Dec 1;25(1):2706. doi:10.1186/S12889-025-23748-3 PubMed PMID: 40781610. Allende-Vigo MZ. Pathophysiologic mechanisms linking adipose tissue and cardiometabolic risk. Endocr Pract. 2010;16(4):692-8. doi:10.4158/EP09340.RA PubMed PMID: 20439246. Di Meo S, Venditti P. Evolution of the Knowledge of Free Radicals and Other Oxidants. Oxid Med Cell Longev. 2020;2020. doi:10.1155/2020/9829176 PubMed PMID: 32411336. Carter AM. Complement Activation: An Emerging Player in the Pathogenesis of Cardiovascular Disease. Scientifica (Cairo). 2012;2012:402783. doi:10.6064/2012/402783 PubMed PMID: 24278688. Goyal A, Tanwar B, Kumar Sihag M, Sharma V. Sacha inchi (Plukenetia volubilis L.): An emerging source of nutrients, omega-3 fatty acid and phytochemicals. Food Chem. 2022 Mar 30;373:131459. doi:10.1016/J.FOODCHEM.2021.131459 PubMed PMID: 34731811.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sacha-Q10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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