NCT00966784Unknown1 期
The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids
研究概览
简要总结
The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will effect the weight and the plasma lipids.
This will be a double-blind parallel controlled study. Study population will include 50 subjects, who will be divided randomly into two groups. The first group will get the Orange juice with fibers, and the second group will get Orange juice with out the fibers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy Volunteers
- •Age 60>18 years
- •Written informed consent
- •Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
- •Regular eating pattern
排除标准
- •Patients with chronic disease sach as:
- •diabetes,
- •C.O.P.D.,
- •metabolic syndrome,
- •over weight,
- •kidney failure,
- •heart disease and
- •osteoporosis.
- •Antibiotic treatment in the last 4 weeks
- •Subjects on regular probiotic or prebiotic supplementation, unless the subject will do 2 weeks of wash out before commencing the study.
- •Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
- •Subjects after intestinal surgery.
- •Use of medicines for lowering cholesterol (simvastatin), sugar control
- •Pregnancy
- •Subjects with abnormal base-line blood test results: liver functions and/or kidney functions, cholesterol level above 200 mg/dL and glucose level above 50 mg/dL (during fast)
结局指标
主要结局
To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids
次要结局
未报告次要终点
研究者
研究点 (2)
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