Sacha Inchi-CoQ10 Supplementation and Cardiovascular Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorHospital Pengajar Universiti Putra Malaysia
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 40 to 75 years.
Male or female.
Able to provide written informed consent.
Able and willing to comply with the study procedures and follow-up visits.
Disqualifiers
Unstable cardiovascular disease.
Severe renal impairment.
Severe hepatic impairment.
Active malignancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacha-Q10 Plus
Dietary supplementParticipants assigned to the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks.
Placebo
Dietary supplementParticipants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sacha Inchi-CoQ10 supplementation GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
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
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: