Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Cardiovascular Risk Factors

In brief

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.

Key facts

Study ID

NCT02490683

Run by

Loma Linda University

People needed

24

Starts

2015-10-01

Expected to finish

2016-05-01

Last updated by the study team

2016-05-12

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women 35-75 years of age, at high risk for cardiovascular disease, i.e. with 2 or more risk factors:
• Present tobacco smoker
• Arterial hypertension (BP ≥140/90 mm Hg or treatment)
• LDL-cholesterol ≥130 mg/dl
• HDL-cholesterol ≤ 40 mg/dl
• Triglycerides ≥150 mg/dl
• Fasting blood glucose ≥110 mg/dl
• Overweight or obesity (BMI ≥ 25 kg/m2)
• Family history of premature heart disease

You may not qualify if…

• Uncontrolled renal/hepatic/endocrine disease
• Abnormal blood chemistry profile
• Familial hypercholesterolemia or other genetic dyslipidaemia
• Intake of lipid-lowering drugs and dietary products including plant sterols/stanols
• High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician
• Hypersensitive or allergic to soy
• Alcohol or drug addiction/abuse
• Diabetics
• Impossibility or lack of interest to follow the dietary intervention

Where it is running

• Loma Linda University School of Public Health — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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