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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oxidized Low Density Lipoprotein
- Sponsor
- Supplement Formulators, Inc.
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Assessment of the mean or median change in Oxidized LDL relative to baseline
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- •Able to communicate, including reading, in English
- •Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline
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)
- •Currently taking or having taken within 30 days before Screening/baseline a multivitamin/mineral product (unless on a consistent daily intake and unlikely to change during the study period)
- •Currently taking or having taken within 30 days before Screening/baseline a supplemental fiber product (unless on a consistent daily intake and unlikely to change during the study period)
Outcomes
Primary Outcomes
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