Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Attack, Hypertension, Stroke
Conditions
Keywords
dietary supplements, cardiovascular diseases, heart attack, stroke, hypertension, amino acids, electrolytes, antioxidants
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.
Interventions
DIETARY_SUPPLEMENTCardioFlex 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.
DIETARY_SUPPLEMENTPlacebo
Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
A 90-day double blinded controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Participant flow
Recruitment details
Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 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. | 35 |
| Control Group 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 | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 33 Participants | 67 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
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.
Time frame: Baseline and 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardioflex Group | Change From Baseline of Total Cholesterol After 90 Days | -0.57 mmol/L | Standard Deviation 1.06 |
| Placebo Group | Change From Baseline of Total Cholesterol After 90 Days | -1.09 mmol/L | Standard Deviation 1.05 |
Comparison: 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.p-value: 0.04295% CI: [-0.846, -0.015]Anaylsis of Covariance
Secondary
Heart Rate Variability
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardioflex Group | Heart Rate Variability | 3.49 ms | Standard Deviation 10.86 |
| Placebo Group | Heart Rate Variability | -6.27 ms | Standard Deviation 10.55 |
Comparison: 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.p-value: 0.0495% CI: [-11.2, -2.24]Anaylsis of Covariance