Sacha Inchi-CoQ10 Supplementation and Cardiovascular Health

NCT07792005 | Not Yet Recruiting

• 1 other identifier: Sacha-Q10
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cardiovascular Disease (CVD); Elevated Cardiovascular Risk; Endothelial Dysfunction

Keywords

Sacha Inchi; Coenzyme Q10; Cardiovascular Disease; Endothelial Function; Oxidative Stress; Inflammation; Nutraceutical; Randomized Controlled Trial; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (1)

• Change from Baseline in Cardiometabolic, Inflammatory and Oxidative Stress Biomarkers, Body Composition, and Safety and Compliance Assessment at Week 12

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

Study Arms (2)

Sacha Inchi-CoQ10 supplementation Group

EXPERIMENTAL

Participants assigned to this arm will receive Sacha Inchi-CoQ10 softgel supplementation, 2 softgels daily for 12 weeks.

Dietary Supplement: Sacha-Q10 Plus

Placebo Group

PLACEBO COMPARATOR

Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

Sacha-Q10 Plus DIETARY_SUPPLEMENT

Participants assigned to the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks.

Sacha Inchi-CoQ10 supplementation Group

Placebo DIETARY_SUPPLEMENT

Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.

Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Pengajar Universiti Putra Malaysia: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Prof. Dr. Chan Yoke Mun

CONTACT

+60 16-391 6589; cym@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share