The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
|ClinicalTrials.gov Identifier: NCT03826914|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : January 30, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Cardiovascular Abnormalities Heart Attack Stroke Hypertension||Dietary Supplement: CardioFlex Q10 Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A 90-day double blinded controlled clinical trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
The selected participants will be randomly assigned in equal numbers to the experimental or control group. Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. Participants in the control group will be given a flavored 10g placebo that looks and tastes exactly like Cardioflex. Participants will be instructed to consume the beverage in 500mL of water upon waking each morning, prior to eating or drinking anything else.
The clinical trial is double blinded so neither the participants or investigators will know which experimental group they are in until the data collection period is over.
|Official Title:||The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults|
|Actual Study Start Date :||November 6, 2018|
|Actual Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Experimental group
Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
Dietary Supplement: CardioFlex Q10
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.
Placebo Comparator: Control Group
Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
Dietary Supplement: Placebo
Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10
- Blood Pressure [ Time Frame: Change from baseline Systolic and Diastolic blood pressure at 90 days. ]Systolic and Diastolic blood pressure
- Inflammatory and endothelial blood work biomarkers [ Time Frame: Change from baseline of Lipoprotein A in mg/dL at 90 days. ]Blood work analysis for Lipoprotein A
- Inflammatory and endothelial blood work biomarkers [ Time Frame: Change from baseline of CRP in mg/L at 90 days. ]Blood work analysis for C-reactive protein
- Inflammatory and endothelial blood work biomarkers [ Time Frame: Change from baseline of IL-6 in pg/mL at 90 days. ]Blood work analysis for Interleukin-6
- Inflammatory and endothelial blood work biomarkers [ Time Frame: Change from baseline of sICAM-1in ng/mL at 90 days. ]Blood work analysis for Soluble intercellular adhesion molecule-1
- Inflammatory and endothelial blood work biomarkers [ Time Frame: Change from baseline of sVCAM-1 in ng/mL at 90 days. ]Blood work analysis for Soluble Vascular Cell Adhesion Molecule-1
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826914
|Richardson Centre for Functional Foods and Nutraceuticals|
|Winnipeg, Manitoba, Canada, R3T 6C5|
|Principal Investigator:||Semone Myrie, PhD||University of Manitoba|