To Assess the Efficacy and Safety of the Cardio Formulation in Reducing Oxidized LDL

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Oxidized Low Density Lipoprotein

Intervention / Treatment
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* Dietary Supplement: Cardio formulation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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) Presence of active or recurring clinically significant conditions as follows: Diabetes mellitus or other endocrine disease Eating disorder Acute or chronic inflammatory disease or autoimmune disease Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke or heart valve problem Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction Thyroid disease (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study period) Hypertension (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study period) Neurologic condition/disease Cancer (unless skin cancer other than melanoma which has been treated > 3 years before Screening/baseline) Liver, pancreatic, and kidney disease Pulmonary disease Blood coagulation disorder or other hematologic disease Other condition or medication use that would preclude participation in the study in the judgment of the Study Investigator/sub-investigator (Sub-I) Currently taking any medication(s) or treatment for a psychiatric disorder (bipolar disorder, manic disorder, schizophrenia, apathetic [inherited] disorder) that include antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants; benzodiazepines; CNS depressants dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines and tramadol. These may preclude participation in the study dependent on the judgment of the investigator/sub-investigator. Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study period) Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) /serum glutaminic- pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL based upon the screening laboratory results or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I Having blood pressure readings at Screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor) Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines). Having any other circumstance that precludes study participation in the judgment of the Study Investigator/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardio formulation<br>Tomato-based formulation with dietary supplement | Dietary Supplement: Cardio formulation<br>* Tomato-based formulation with dietary supplement softgels<br>|
| Placebo Comparator: Placebo<br>Placebo softgels | Dietary Supplement: Placebo<br>* Placebo softgels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mean or median change in Oxidized LDL relative to baseline | Mean or median change in Oxidized LDL from baseline to Day 60 | 60 days |