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

January 12, 2023 updated by: Supplement Formulators, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Lfie Extension Clinical Reseach, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ambulatory, male or female, 40-75 years of age
  2. A BMI of 25-34.9 and/or waist circumference > 40.0 inches in males and > 35.0 inches in females
  3. 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
  4. Generally healthy and having no significant difficulty with digestion or absorption of food
  5. Has been generally weight stable for the past six months (+ 6 lbs.)
  6. Willing and able to give written informed consent
  7. Clearly understands the procedures and study requirements
  8. Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
  9. Able to communicate, including reading, in English
  10. 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:

  1. 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
  2. Donated blood within 30 days before Screening/baseline
  3. Inability to provide a venous blood sample
  4. Participation in another study within 30 days prior to Screening/baseline
  5. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
  6. 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
  7. 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
  8. 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)
  9. 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)
  10. 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)

  11. 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)
  12. 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.
  13. 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)
  14. 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
  15. 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
  16. 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
  17. 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)
  18. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
  19. History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines).
  20. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardio formulation
Tomato-based formulation with dietary supplement
Dietary supplement: Cardio formulation
Tomato-based formulation with dietary supplement softgels
Placebo Comparator: Placebo
Placebo softgels
Dietary supplement: Placebo
Placebo softgels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CL099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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