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

NCT ID: NCT03826914

Last Updated: 2020-10-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2020-08-01

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.

Conditions

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Cardiovascular Diseases Cardiovascular Abnormalities Heart Attack Stroke Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 90-day double blinded controlled clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Experimental group

Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.

Group Type EXPERIMENTAL

CardioFlex Q10

Intervention Type DIETARY_SUPPLEMENT

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.

Control Group

Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Semone Myrie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. doi: 10.1161/01.cir.0000048890.59383.8d. No abstract available.

Reference Type BACKGROUND
PMID: 12515760 (View on PubMed)

Nunez-Cordoba JM, Martinez-Gonzalez MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. doi: 10.2174/156802611796235143.

Reference Type BACKGROUND
PMID: 21506930 (View on PubMed)

Manson JE, Gaziano JM, Jonas MA, Hennekens CH. Antioxidants and cardiovascular disease: a review. J Am Coll Nutr. 1993 Aug;12(4):426-32. doi: 10.1080/07315724.1993.10718332.

Reference Type BACKGROUND
PMID: 8409105 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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CardioFLex Q10

Identifier Type: -

Identifier Source: org_study_id