Nutritional Clinical Trial to Evaluate the Efficacy of Daily Consumption for 12 Weeks of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Muscle function
研究概览
简要总结
Controlled, randomized, single-center, double-blind clinical trial, with two parallel branches depending on the product consumed, to measure the efficacy of a supplement extracted from spinach on muscle strength in subjects over 50 years of age.
详细描述
Subjects who meet the selection criteria will make two visits to the laboratory to perform the tests established in the protocol. In addition, all subjects will develop a program of strength, polyarticular, individualized and progressive exercises in which the main muscle groups are worked. The program will be held three days a week (36 sessions). Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 75 years.
- •Body mass index less than
- •Subjects who do not develop physical exercise scheduled on a weekly basis.
- •Subjects who have given written informed consent to participate in the study.
排除标准
- •Consumption during the 6 months prior to the study of functional food or supplement that modifies body composition.
- •Presence of absolute or relative contraindications dictated by the American College of Sports Medicine, for the performance of physical exercise.
- •Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, ischemic heart disease under treatment, arrhythmias, etc.).
- •Abuse in the ingestion of alcohol.
- •Present hypersensitivity or intolerance to any of the components of the products under study.
- •Inability to understand informed consent.
- •Serious or terminal illnesses.
- •Subjects with a body mass index above
- •Pregnant or lactating women.
- •Inability to understand informed consent.
结局指标
主要结局
Muscle function
时间窗: From baseline to 90 days
Isokinetic dynamometry. Knee flexion and extension force
次要结局
- Health Questionnaire(From baseline to 90 days)
- Liver safety variables(It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.)
- Balance(From baseline to 90 days)
- Nutritional survey(From baseline to 90 days)
- Muscle mass(From baseline to 90 days)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia