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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04317287
Recruitment Status : Active, not recruiting
First Posted : March 23, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

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.

Condition or disease Intervention/treatment Phase
Oxidized Low Density Lipoprotein Dietary Supplement: Cardio formulation Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : April 9, 2021
Estimated Study Completion Date : April 30, 2021

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317287


Locations
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United States, Florida
Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
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Principal Investigator: Andrew Swick, Ph.D LIfe Extension
Publications:
Ali, W., Kushwaha, U., Wamique, M., & et al. (2017). Oxidized LDL as a Biomarker in Metabolic Syndrome. J Diabetes Metab, 8(9), 1-5.
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. Erratum in: Circulation. 2020 Jan 14;141(2):e33.
Clinic, M. (n.d.). PCSK9 inhibtion: A game changer in cholesterol management. Retrieved from Cardiovascular Diseases: 1 https://www.mayoclinic.org/medical-professionals/cardiovascular-diseases/news/pcsk9-inhibition-a-game-changer-in-cholesterol-management/mac-20430713
Dallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
Diseases, I. o. (2011). A Nationwide Framework for Surveillance of Cardiovascular and Chronic Lung Diseases. Washington, DC: National Academies Press.
Drugs.com. (n.d.). Retrieved 2019, from Resveratrol: https://www.drugs.com/resveratrol.html
Office of New Drugs. (2005). Guidance for Industry on esitmating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Federal Register, 70(140), 1-37. Retrieved from https://www.fda.gov/media/72309/download
Program, I. I. (2012, April 18). Lycopene Handling. Retrieved from United States Department of Agriculture: https://www.ams.usda.gov/sites/default/files/media/Lycopene%20TR.pdf
Rosner, B. (n.d.). Hypothesis Testing: Two-Sample Inference- Estimation of Sample Size and Power for Comparing Two Means. In B. Posner, Fundamentals of Biostatistics. Cengage Learning.
Williams, J., Ensor, M., Smith, R., & et al. (2016). 4-week tosicity and toxicokinetic oral gavage study with polydatin in rats. WebmedCentral TOXICOLOGY, 7(11), 1-19. doi:wmc995231
www.Randomization.com. (2017, July 10). Retrieved from Randomization.com: http://www.randomization.com

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Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT04317287    
Other Study ID Numbers: CL099
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No