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

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT03826914
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.8
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Attack; Stroke; Hypertension	Dietary Supplement: CardioFlex Q10; Dietary Supplement: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A 90-day double blinded controlled clinical trialA 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: Nov 6, 2018
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline of Total Cholesterol After 90 Days [Baseline and 90 days]

   Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.

Secondary Outcome Measures

1. Heart Rate Variability [Baseline and day 90]

   Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba	Canada	R3T 6C5

Sponsors and Collaborators

• University of Manitoba

Investigators

• Principal Investigator: Semone Myrie, PhD, University of Manitoba

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 1, 2020

More Information

Publications

• 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.
• Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5.
• Núñez-Córdoba JM, Martínez-González MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. Review.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT03826914
• Other Study ID Numbers: CardioFLex Q10
• First Posted: Feb 1, 2019
• Last Update Posted: Oct 29, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Hypertension; Cardiovascular Diseases; Myocardial Infarction; Cardiovascular Abnormalities

Study Results

Participant Flow

Recruitment Details	Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. 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.	Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10. Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10
Period Title: Overall Study
STARTED	35	34
COMPLETED	34	33
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Experimental Group	Control Group	Total
Arm/Group Description	Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. 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.	Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10. Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10	Total of all reporting groups
Overall Participants	35	34	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 97.1%	33 97.1%	67 97.1%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	22 62.9%	18 52.9%	40 58%
Male	12 34.3%	15 44.1%	27 39.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioflex Group	Placebo Group
Arm/Group Description	Participants were given 1 serving (10g) of Cardioflex each day.	Participants in the placebo group were given 10g of a maltodextrin placebo per day
Measure Participants	34	33
Mean (Standard Deviation) [mmol/L]	-0.57 (1.06)	-1.09 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cardioflex Group, Placebo Group
	Comments	The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments	The threshold of significance was P=0.05
	Method	Anaylsis of Covariance
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.846 to -0.015
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo - Cardioflex

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioflex	Placebo
Arm/Group Description	Participants in the Cardioflex group were given 1 serving (10g) of Cardioflex each day.	Participants in the placebo group were given 10g of a maltodextrin placebo each day.
Measure Participants	34	33
Mean (Standard Deviation) [ms]	3.49 (10.86)	-6.27 (10.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cardioflex Group, Placebo Group
	Comments	The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	The threshold of significance was P=0.05
	Method	Anaylsis of Covariance
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.772
	Confidence Interval	(2-Sided) 95%; -11.2 to -2.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events were monitored over the 90 day study period.
Arm/Group Title	Experimental Group		Control Group
Arm/Group Description	Participants were given one serving (10g) of cardioflex daily for 90 consecutive days.		Participants were given one serving of an isocaloric maltodextrin placebo daily for 90 consecutive days.
All Cause Mortality
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Serious Adverse Events
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.