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

Not Applicable
Completed
Conditions
Cardiovascular Diseases
Cardiovascular Abnormalities
Hypertension
Heart Attack
Stroke
Interventions
Dietary Supplement: CardioFlex Q10
Dietary Supplement: Placebo
Registration Number
NCT03826914
Lead Sponsor
University of Manitoba
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
69
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupCardioFlex Q10Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
Control GroupPlaceboParticipants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
Primary Outcome Measures
NameTimeMethod
Change From Baseline of Total Cholesterol After 90 DaysBaseline and 90 days

Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.

Secondary Outcome Measures
NameTimeMethod
Heart Rate VariabilityBaseline and day 90

Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals

🇨🇦

Winnipeg, Manitoba, Canada

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