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

U

University of Manitoba

Status

Completed

Conditions

Hypertension
Stroke
Cardiovascular Abnormalities
Heart Attack
Cardiovascular Diseases

Treatments

Dietary Supplement: Placebo
Dietary Supplement: CardioFlex Q10

Study type

Interventional

Funder types

Other

Identifiers

NCT03826914
CardioFLex Q10

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

69 participants in 2 patient groups, including a placebo group

Experimental group
Experimental group
Description:
Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
Treatment:
Dietary Supplement: CardioFlex Q10
Control Group
Placebo Comparator group
Description:
Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
Treatment:
Dietary Supplement: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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