Obesity Clinical Trial
Official title:
The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
Verified date | January 2016 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | January 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. 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 Exclusion Criteria: 1. Uncontrolled renal/hepatic/endocrine disease 2. Abnormal blood chemistry profile 3. Familial hypercholesterolemia or other genetic dyslipidaemia 4. Intake of lipid-lowering drugs and dietary products including plant sterols/stanols 5. High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician 6. Hypersensitive or allergic to soy 7. Alcohol or drug addiction/abuse 8. Diabetics 9. Impossibility or lack of interest to follow the dietary intervention |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University School of Public Health | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum Lipid profile | Serum Low density cholesterol, high density cholesterol, apo Lipoprotein A and B, apo E allele genetic typing and triglycerides will be measured from the by performing lab tests. | baseline- 30 weeks | No |
Primary | Inflammatory and oxidative parameters | hs-CRP (highly sensitive C-reactive protein), TNF-alpha (tissue necrosis factor alpha), IL-6 (Interleukin 6), ox-LDL (oxidized low density lipoprotein), TBARS (thiobarbituric acid reactive substances) lipid peroxides, 8-OHdG (8-hydroxy-2-deoxyguanosine) will be measured via lab tests | baseline- 30 weeks | No |
Secondary | Hormones | : adiponectin, leptin, insulin, C-peptide (C-peptide of insulin); and fasting glucose and hemoglobin A1c. will be measured via lab tests | baseline- 30 weeks | No |
Secondary | Compliance | , blood samples will be taken for testing levels of lunasin and/or its metabolites as biological marker(s) of the treatment compliance. | baseline -30 weeks | No |
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