Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lesieur
- 入组人数
- 149
- 试验地点
- 4
- 主要终点
- Changes in bone mineral density
研究概览
简要总结
The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described.
Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction.
Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 57 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Caucasian female
- •Within at least 7 years post-menopause
- •Generally healthy as determined by standard medical assessment on physical and mental health
- •Normal weight as determined by BMI (20≤ BMI ≤30)
- •Affiliated to National Health Insurance
- •Willing to comply with the study procedures
- •Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
- •Having received both oral and written explanations about the study
- •Having provided her written informed consent
排除标准
- •Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition
- •Osteoporosis (defined by T-score of -2.5 standard deviation (SD) at hip and/or spine)
- •On therapy with drugs known to interfere with bone and muscle metabolism
- •Taking regular calcium and vitamin D supplements
- •Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study•
- •Intense Physical activity
结局指标
主要结局
Changes in bone mineral density
时间窗: at baseline and after 9 months of supplementation
次要结局
- Changes in serum markers of bone resorption(At baseline, 3 and 9 months)
- changes in serum markers of bone formation(At baseline, 3 and 9 months)