The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
Primary Purpose
Cardiovascular Diseases, Cardiovascular Abnormalities, Heart Attack
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CardioFlex Q10
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring dietary supplements, cardiovascular diseases, heart attack, stroke, hypertension, amino acids, electrolytes, antioxidants
Eligibility Criteria
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
Sites / Locations
- Richardson Centre for Functional Foods and Nutraceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control Group
Arm Description
Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Heart Rate Variability
Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score
Full Information
NCT ID
NCT03826914
First Posted
November 29, 2018
Last Updated
October 7, 2020
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03826914
Brief Title
The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
Official Title
The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cardiovascular Abnormalities, Heart Attack, Stroke, Hypertension
Keywords
dietary supplements, cardiovascular diseases, heart attack, stroke, hypertension, amino acids, electrolytes, antioxidants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 90-day double blinded controlled clinical trial
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
Intervention Type
Dietary Supplement
Intervention Name(s)
CardioFlex Q10
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10
Primary Outcome Measure Information:
Title
Change From Baseline of Total Cholesterol After 90 Days
Description
Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.
Time Frame
Baseline and 90 days
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score
Time Frame
Baseline and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semone Myrie, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 6C5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12515760
Citation
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.
Results Reference
background
PubMed Identifier
21506930
Citation
Nunez-Cordoba JM, Martinez-Gonzalez MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. doi: 10.2174/156802611796235143.
Results Reference
background
PubMed Identifier
8409105
Citation
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.
Results Reference
background
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The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
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