The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults

Study Overview
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Brief Summary
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Cardiovascular diseases (CVD), primarily heart disease and stroke, are the leading causes of death and prescription drug use in Canada. Research on certain dietary supplements looks promising as a way to help reduce CVD risk factors. Studies show that supplementation of certain nutrients such as antioxidants, amino acids, electrolytes, vitamins and minerals may effectively reduce cardiovascular risk factors. The dietary supplement CardioFlex Q10, which is high in the aforementioned components, was developed to help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation. The overall objective of this study is to determine if 90 days of supplementing with CardioFlex Q10 can reduce CVD risk factors in adults, independent of other dietary or physical activity changes.

Detailed Description
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The purpose of this study is to determine whether or not daily supplementation with the dietary supplement CardioFlex Q10 for 90 days can reduce cardiovascular risk factors in healthy adults. The health markers that will be tested include the participant's waist circumference, body weight, body mass index (BMI), atherosclerosis risk factors (blood pressure, plethysmogram (PTG) wave form, heart rate variability, accelerated plethysmograph (APG) type (biological age of arteries)), and blood work including total plasma lipid profile (total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TGs)), kidney and liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), Blood Urea Nitrogen (BUN), creatinine), and inflammatory and endothelial function biomarkers (C-reactive protein (CRP), Interleukin-6 (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1) ). All health markers will be tested the day before starting the study and the day after the study is completed.

Official Title
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The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults

Conditions
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Cardiovascular Diseases, Cardiovascular Abnormalities, Heart Attack, Stroke, Hypertension

Intervention / Treatment
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* Dietary Supplement: CardioFlex Q10
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30-65 An accelerated plethysmograph (APG) type (biological age of arteries) of D, E, F or G and/or a high density lipoprotein (HDL) to total cholesterol (TC) ratio of ≤24 percent Exclusion Criteria: Have used prescription cholesterol or blood pressure medication in the last 3 months Perform more then 150 minutes of moderate to rigorous activity per week Pregnant or planning on getting pregnant during the study period

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 90-day double blinded controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. | Dietary Supplement: CardioFlex Q10<br>* CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.<br>|
| Placebo Comparator: Control Group<br>Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex. | Dietary Supplement: Placebo<br>* Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Total Cholesterol After 90 Days | Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score. | Baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score | Baseline and day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary supplements, cardiovascular diseases, heart attack, stroke, hypertension, amino acids, electrolytes, antioxidants