Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Upper limb fat mass
研究概览
简要总结
Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.
详细描述
The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out 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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes with age between 55-70 years.
- •Body mass index less than
- •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 enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
- •Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
- •Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, 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.
结局指标
主要结局
Upper limb fat mass
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Muscle mass
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Total fat free mass
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Lower limb fat mass
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Total fat mass
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Fat free mass on upper limb
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Fat-free mass in the lower limb
时间窗: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
次要结局
- Elbow extension(This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).)
- Blood samples: Glycid metabolism and lipid metabolism.(Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.)
- Elbow flexion(This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).)
- Knee extension(This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).)
- Knee flexion(This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).)
- Liver safety variables(Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia