Obesity Clinical Trial
Official title:
The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
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.
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.)
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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