Sacha Inchi-CoQ10 Supplementation and Cardiovascular Health

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

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.

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.