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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826914
• Other study ID #: CardioFLex Q10
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2019
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Cardiovascular Diseases
• Heart Attack
• Hypertension
• Myocardial Infarction
• Stroke

Intervention

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
Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Manson JE, Gaziano JM, Jonas MA, Hennekens CH. Antioxidants and cardiovascular disease: a review. J Am Coll Nutr. 1993 Aug;12(4):426-32. Review. — View Citation

Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. — View Citation

Núñez-Córdoba JM, Martínez-González MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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