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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826914
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Abnormalities Heart Attack Stroke Hypertension Dietary Supplement: CardioFlex Q10 Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 90-day double blinded controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

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.

Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Change from baseline Systolic and Diastolic blood pressure at 90 days. ]
    Systolic and Diastolic blood pressure


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 30-55
  • A resting pulse rate of 60 beats per minute (BPM) or higher
  • An accelerated plethysmograph (APG) type (biological age of arteries) of D, E, F or G
  • A high density lipoprotein (HDL) to total cholesterol (TC) ratio of ≤24 percent
  • A triglyceride (TG) to HDL ratio ≥ 2 percent
  • Contain a minimum of 2 traits of metabolic syndrome
  • Perform less then 150 minutes of moderate to rigorous activity per week
  • Not pregnant or planning on getting pregnant during the study
  • Have not used prescription cholesterol or blood pressure medication in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826914


Locations
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Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 6C5
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Semone Myrie, PhD University of Manitoba
Additional Information:
Publications:
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03826914    
Other Study ID Numbers: CardioFLex Q10
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
dietary supplements
cardiovascular diseases
heart attack
stroke
hypertension
amino acids
electrolytes
antioxidants
Additional relevant MeSH terms:
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Hypertension
Myocardial Infarction
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Congenital Abnormalities
Myocardial Ischemia
Heart Diseases