Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.
Condition: Obesity; Cardiovascular Risk Factors
Study type: Interventional

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.
    

Detailed 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.)
    

Intervention name(s): Luna Rich X; Placebo; Reliv Now
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention