Trial Outcomes & Findings for The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults (NCT NCT03826914)
NCT ID: NCT03826914
Last Updated: 2020-10-29
Results Overview
Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Baseline and 90 days
Results posted on
2020-10-29
Participant Flow
Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
Baseline characteristics by cohort
| Measure |
Experimental Group
n=35 Participants
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.
|
Control Group
n=34 Participants
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
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
0 Participants
n=33 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
0 Participants
n=67 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=34 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
33 Participants
n=33 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
67 Participants
n=67 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
0 Participants
n=33 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
0 Participants
n=67 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
|
Sex: Female, Male
Female
|
22 Participants
n=34 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
18 Participants
n=33 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
40 Participants
n=67 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
|
Sex: Female, Male
Male
|
12 Participants
n=34 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
15 Participants
n=33 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
27 Participants
n=67 Participants • 2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline and 90 daysTotal cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.
Outcome measures
| Measure |
Cardioflex Group
n=34 Participants
Participants were given 1 serving (10g) of Cardioflex each day.
|
Placebo Group
n=33 Participants
Participants in the placebo group were given 10g of a maltodextrin placebo per day
|
|---|---|---|
|
Change From Baseline of Total Cholesterol After 90 Days
|
-0.57 mmol/L
Standard Deviation 1.06
|
-1.09 mmol/L
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline and day 90Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score
Outcome measures
| Measure |
Cardioflex Group
n=34 Participants
Participants were given 1 serving (10g) of Cardioflex each day.
|
Placebo Group
n=33 Participants
Participants in the placebo group were given 10g of a maltodextrin placebo per day
|
|---|---|---|
|
Heart Rate Variability
|
3.49 ms
Standard Deviation 10.86
|
-6.27 ms
Standard Deviation 10.55
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place