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 range40 Years – 75 Years
SexALL
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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
✓. 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
What they're measuring
1
Assessment of the mean or median change in Oxidized LDL relative to baseline
. 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)