Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Serum b-cryptoxanthin
研究概览
简要总结
We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and 2) we will study in post-menopausal women (target group) the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages (containing b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone turnover and cardiovascular risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women, 45-60 years old
排除标准
- •Food allergy (to any components provided)
- •Hormone replacement therapy
- •Cholesterol lowering drugs, antiresorptive or anabolic bone drugs
- •Calcium and vitamin D supplements
- •Soybean products
- •Vitamin-mineral supplements
- •Fibre supplements
- •Commercially available enriched foods (i.e. w-3, phytosterols,carotenoids,...)
结局指标
主要结局
Serum b-cryptoxanthin
时间窗: 4 weeks
次要结局
- Serum Cardiovascular risk markers(4 weeks)
- Serum bone markers(4 weeks)
- Genetic variability (polymorphisms)and DNA oxidative damage(4 weeks)
研究者
Fernando Granado Lorencio
Dr. Fernando Granado lorencio
Puerta de Hierro University Hospital