The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Serum Lipid profile
研究概览
简要总结
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.
详细描述
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
- 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.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Impossibility or lack of interest to follow the dietary intervention
研究组 & 干预措施
Luna Rich X
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
干预措施: Luna Rich X (Dietary Supplement)
Reliv Now
19 grams of power/day, that subjects will mix and consume daily with water or a beverage they commonly drink
干预措施: Reliv Now (Dietary Supplement)
Placebo
Placebo pills containing starch (provided by Reliv International, Inc.)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Serum Lipid profile
时间窗: baseline- 30 weeks
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.
Inflammatory and oxidative parameters
时间窗: baseline- 30 weeks
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
次要结局
- Compliance(baseline -30 weeks)
- Hormones(baseline- 30 weeks)
研究者
Joan Sabate,DrPH, MD
DrPH, MD
Loma Linda University