The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To test the effects of Q CAN PLUS powder, on serum lipids
研究概览
简要总结
This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation
详细描述
The purpose of this research study is to investigate the effects of a dietary supplement from soybeans that might help in managing heart disease. The rationale for this study is to reduce the risk factors of heart disease in high risk individuals by using soy supplements. The dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects in free-living conditions. There will be a two week run-in (acclimation period) after which subjects will be randomized to receive either QCAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over(cross over) to alternate treatment. Thus, the interventions of the study will last for a total of 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the participants and the investigators will not be aware of which powder is the active powder and which one is the placebo. Only the Principle Investigator will be made aware.
入排标准
- 年龄范围
- 29 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 29-75 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 ≥ 110 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, or endocrine disease
- •Abnormal blood chemistry profile
- •Familial hypercholesterolemia or other genetic dyslipidemia
- •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 or cellulose
- •Alcohol or drug addiction or abuse
- •Lack of ability or interest to follow the dietary intervention
结局指标
主要结局
To test the effects of Q CAN PLUS powder, on serum lipids
时间窗: baseline to 7 months
This is a composite measurement which will measure the change in the levels of serum Low Density Cholesterol, High Density Cholesterol, ApoLipoprotein A and B, APO E Allele genetic typing and triglycerides before the ingestion of QCAN PLUS powder and at 7 months after ingestion of Q CAN PLUS powder.
Inflammatory parameter
时间窗: baseline to 7 months
to test the changes in concentration of hs-CRP (highly sensitive C reactive protein) in the blood prior to ingestion of Q CAN PLUS powder and again at 7 months after ingestion of Q CAN PLUS Powder
次要结局
- Fasting Glucose(baseline to 7 months)
研究者
Joan Sabate,DrPH, MD
Professor of Nutrition
Loma Linda University