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

NCT04317287 | Terminated

• 1 other identifier: CL099
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidized Low Density Lipoprotein

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cardio formulation

EXPERIMENTAL

Tomato-based formulation with dietary supplement

Dietary Supplement: Cardio formulation

Placebo

PLACEBO COMPARATOR

Placebo softgels

Dietary Supplement: Placebo

Interventions

Cardio formulation DIETARY_SUPPLEMENT

Tomato-based formulation with dietary supplement softgels

Cardio formulation

Placebo DIETARY_SUPPLEMENT

Placebo softgels

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Lfie Extension Clinical Reseach, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

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Study Officials

• Andrew Swick, Ph.D

  LIfe Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: December 10, 2019
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)