To Assess the Efficacy and Safety of the Cardio Formulation in Reducing Oxidized LDL
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|ClinicalTrials.gov Identifier: NCT04317287|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2020
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oxidized Low Density Lipoprotein||Dietary Supplement: Cardio formulation Dietary Supplement: Placebo||Not Applicable|
This is a double-blind, randomized, placebo-controlled, parallel design study to evaluate the effectiveness of the Cardio formulation in reducing oxidized LDL. Each subject will receive a specific dose of the study product to be taken with a meal daily preferably at the same time each day with water.
Participants will receive questionnaires, assessments, blood tests, vital signs and body composition analysis.
The primary objective is the evaluation of the change in Ox LDL in response to the Cardio formulation at Days 30 and 60 relative to baseline compared with placebo.
The secondary objective is the evaluation of the change in anthropometric measurements, clinical laboratory evaluations, and health survey scores in response to the Cardio formulation at Days 30 and Day 60 relative to baseline compared with placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Double-blind, Randomized, Placebo-controlled, Parallel Design Study to Evaluate the Effects of the Cardio Formulation on Oxidized LDL in Individuals Who Are Overweight to Mildly Obese and Otherwise Healthy|
|Actual Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||April 9, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Cardio formulation
Tomato-based formulation with dietary supplement
Dietary Supplement: Cardio formulation
Tomato-based formulation with dietary supplement softgels
Placebo Comparator: Placebo
Dietary Supplement: Placebo
- Assessment of the mean or median change in Oxidized LDL relative to baseline [ Time Frame: 60 days ]Mean or median change in Oxidized LDL from baseline to Day 60
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317287
|United States, Florida|
|Lfie Extension Clinical Reseach, Inc.|
|Fort Lauderdale, Florida, United States, 33308|
|Principal Investigator:||Andrew Swick, Ph.D||LIfe Extension|