NCT02218333已完成不适用
Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in muscle mass, strength and performance
研究概览
简要总结
The aim of the present study is to investigate effects of milk on body composition and muscle strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in elderly subjects.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 70 years of age
- •reduced gait speed or
- •reduced "five times sit to stand test" or
- •reduced "timed step stair test " or
- •reduced grip strength
- •Stable body weight (last 3 months)
- •Mini Nutritional Assessment (MNA®) score ≥ 17
- •Mini-mental status (MMSE-NR) score: ≥ 24
- •Willing to participate according to the protocol
排除标准
- •Allergy/intolerance to milk/dairy products
- •High intake of milk and yoghurt
- •Physical active subjects
- •Known diabetes type I or II, or HbA1c ≥ 6,5%
- •Recent events of acute cardiovascular disease including stroke
- •Rapidly evolving diseases (active malignancy) or history of cancer (malignant tumors) last 3 years.
- •Severe inflammation-related diseases such as e.g. Crohn disease and arthritis
- •Chronic obstructive pulmonary disease
- •Increased blood pressure
- •High intake of alcohol
- •Reduced kidney function (GFR < 45 ml/min)
- •Increased hsCRP, ASAT, ALAT
- •Increased or suppressed TSH
- •Hormone therapy
- •Systemic use of glucocorticosteroids (anti-inflammatory steroid hormones). Use of spray and inhalator use is not exclusion.
- •Disability preventing physical tests
- •Using medications known to affect protein metabolism
结局指标
主要结局
Change in muscle mass, strength and performance
时间窗: Measured at baseline and after 12 weeks (end-of-study visit)
Change in muscle is mass measured by DXA. Muscle strength and performance are measured by several physical tests such as repeated chair stands, handgrip strength, step stair test and strength in legs and torso and gait speed and are considered as the clinical relevant outcomes.
次要结局
- Changes in levels of inflammatory markers(Measured at baseline and after 12 weeks (end-of-study visit))
研究者
Kirsten Holven
Professor
University of Oslo
研究点 (2)
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