To Assess the Efficacy and Safety of the Cardio Formulation in Reducing Oxidized LDL (NCT04317287) | Clinical Trial Compass
TerminatedNot Applicable
To Assess the Efficacy and Safety of the Cardio Formulation in Reducing Oxidized LDL
Stopped: COVID-19 Pandemic
United States9 participantsStarted 2019-12-10
Plain-language summary
The purpose of this study is to assess the efficacy and safety of the Cardio formulation in reducing oxidized LDL \[(Ox LDL (low density lipoprotein)\] in overweight to mildly obese generally healthy adults.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ambulatory, male or female, 40-75 years of age
. A BMI of 25-34.9 and/or waist circumference \> 40.0 inches in males and \> 35.0 inches in females
. Having a fasting LDL cholesterol level of \>100- \<189 mg/dL OR, total cholesterol level of \> 200-\< 239 mg/dL OR triglycerides level of \> 150 mg/dl - \< 199 mg/dl OR blood sugar level \> 100 mg/dl - \< 126 mg/dl based upon the screening laboratory results from the Complete Blood Count (CBC)/Chemistry profile
. Generally healthy and having no significant difficulty with digestion or absorption of food
. Has been generally weight stable for the past six months (+ 6 lbs.)
. Willing and able to give written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the mean or median change in Oxidized LDL relative to baseline
. Clearly understands the procedures and study requirements
. Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
Exclusion criteria
. Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days
. Donated blood within 30 days before Screening/baseline
. Inability to provide a venous blood sample
. Participation in another study within 30 days prior to Screening/baseline
. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
. History of allergy or sensitivity to any component of the study products including tomatoes, lycopene, Japanese knotweed (Reynoutria japonica, Fallopia japonica, Polygonum cuspidatum) phytosterols, mixed tocopherols, phytoene and phytofluene and beta carotene, polydatin, resveratrol, gelatin, glycerin, or coconut oil
. Currently taking or having taken within 30 days before Screening/baseline a cholesterol-lowering medication(s) including 3-hydroxy-3-methylglutaric acid-CoA (HMG-CoA) reductase inhibitors, cholesterol binding resins, niacin \> 500 mg/day, or fibrates
. Currently taking or having taken within 30 days before Screening/baseline a dietary supplement/food that may affect cholesterol levels including niacin \> 500 mg/day, red yeast rice, red mold dioscorea, guggulipid, policosanol, pantethine \> 300 mg/day, beta-sitosterol, artichoke leaf, L-carnitine, and nuts (including almonds, walnuts, hazelnuts, pecans and pistachios \> 1oz. per day)