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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. |
|
| Control Group | Placebo Comparator | Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioFlex Q10 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score | Baseline and day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semone Myrie, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richardson Centre for Functional Foods and Nutraceuticals | Winnipeg | Manitoba | R3T 6C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12515760 | Background | 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. | |
| 21506930 | Background | Nunez-Cordoba JM, Martinez-Gonzalez MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. doi: 10.2174/156802611796235143. |
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Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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69 participants started the clinical trial, 35 in the Cardioflex group and 34 in the Placebo group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 90 days |
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Adverse events were monitored over the 90 day study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | Participants were given one serving (10g) of cardioflex daily for 90 consecutive days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Semone Myrie | University of Manitoba | (204) 474-7290 | semone.myrie@umanitoba.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 1, 2020 | Oct 6, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D018376 | Cardiovascular Abnormalities |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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A 90-day double blinded controlled clinical trial
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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.
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| Placebo | Dietary Supplement | Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10 |
|
| 8409105 | Background | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
|
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| Secondary | Heart Rate Variability | Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score | Posted | Mean | Standard Deviation | ms | Baseline and day 90 |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group | Participants were given one serving of an isocaloric maltodextrin placebo daily for 90 consecutive days. | 0 | 34 | 0 | 34 | 0 | 34 |
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| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |