Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.

Obesity Clinical Trial

Official title: The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease

Status Active, not recruiting

Clinical Trial Summary

This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or powder (control) on blood lipids. It will also explore the potential effects of these dietary supplements on inflammation markers and other biological and anthropometric measures. The study intervention will be 30 weeks in length. Twenty four subjects with 2 or more cardiometabolic risk factors will be randomized to participate in the study.

Clinical Trial Description

Primary Objective To test the effects of Luna Rich X©, and Reliv Now© on serum lipids and selected inflammatory and oxidative parameters.

Secondary Objective To explore the potential effects of Luna Rich X© and Reliv Now© on body weight and adiposity.

Hypotheses

1. Eight-week supplementation of formulated lunasin-enriched soy concentrate (Luna Rich X©) in adults at risk for cardiovascular disease will improve their serum lipid profile and reduce inflammatory parameters.

2. Eight-week supplementation of a formulated soy-based powder (Reliv Now) plus Luna Rich X in adults at risk for cardiovascular disease will improve their serum lipid profile and reduce inflammatory parameters.

Study Protocol

Recruitment of Subjects Subjects will be recruited from out-patient clinics in or near Loma Linda University. In collaboration with the medical personnel of the Family and Internal Medicine clinics of the Loma Linda University and Beaver Medical Group, interested clients/patients will be referred to the study. Potential subjects will be informed about the study by the physician, nurse or other clinic personnel and will be given a flyer. Individuals will make their own decision whether or not to participate in the study. The clients/patients who will be interested in participating in the study will contact the investigators via the provided phone numbers. A dedicated telephone line and webpage will provide both additional information to interested individuals and a means to screen out subjects by the study personnel. Potential subjects will first be screened by study personnel, and then directed to a clinical laboratory at Loma Linda University for determination of biochemical parameters on which the eligibility for the study will be determined.

Dietary Interventions

• Luna Rich X©: 500 mg/ day in 4 pills of lunasin-enriched soy protein concentrate

• Reliv Now: 19 grams of powder/day, that subject will mix and consume daily with water or a beverage they commonly drink.

• Control: Placebo pills containing starch (provided by Reliv International, Inc.) ;

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Obesity

• NCT number: NCT02490683
• Study type: Interventional
• Source: Loma Linda University
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Completion date: January 2017