NCT04317287

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oxidized Low Density Lipoprotein

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cardio formulation	Tomato-based formulation with dietary supplement softgels
DIETARY_SUPPLEMENT	Placebo	Placebo softgels

Timeline

• Start date: 2019-12-10
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2020-03-23
• Last updated: 2023-01-13

Locations

1 site across 1 country: United States