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临床试验/NCT02001831
NCT02001831Unknown不适用

Effect of a Nutrition Supplement Containing Fish Oil, Whey Protein, Vitamin D, and Resveratrol, on Muscular and Cognitive Function in Older Adults

University College Dublin2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Total and appendicular muscle mass

研究概览

简要总结

The aims of the present study are:

i. To conduct a population study of body composition, muscle function and ability to undertake activities of daily living in elderly Irish individuals

ii. To investigate the effect of a six month period of nutrition supplement support on lean tissue mass, and muscle and cognitive function in individuals aged 70 to 80 years.

详细描述

The study is a population study and 6 month randomised control trial (RCT) of men and women aged 70 to 80. The supplement and placebo will be provided in the form of a small 200 mL sealed TetraPak carton and is presented in a highly-palatable, juice-based (pomegranate and apple) formulation. The study groups (n=25 per group) for the RCT are:

Control - a control group receiving a placebo nutrient support (200 mL juice; energy ~ 100 kcal per day)

Supplement - a nutrient group receiving a liquid nutrient support (quantity 200 mL per day; energy 200 kcal per day):

Carbohydrate 28.5 g Protein 8 g as Whey Protein Isolate (i) ω-3 PUFA (ii) 3000 mg, as DHA 1500mg, as EPA 1500mg Vitamin D3 (iii) 10 μg Resveratrol (iv) 150 mg

(i) Whey protein isolate - increasing protein intake in elderly individuals is widely proposed as key preventing the decline in muscle mass with aging, (ii) ω-3/EPA/DHA fatty acids - increasing ω-3 consumption is associated with improvements in inflammatory status, blood lipid profile and cognitive function in various populations (iii) A relative deficiency in vitamin D is widely reported in Western populations, whereas recent reports have suggested vitamin D3 supplementation as efficacious for muscle function, (iv) Resveratrol, a polyphenol derived from grape skin that shows promise as a supplement to improve muscle function, metabolic health, prevent wasting and promote longevity.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 70 years of age
  • Medically stable, according to Greig et al. (1994)
  • BMI between 20 and 30 kg/m2
  • Sedentary lifestyle, defined by ≤125 min/week of activity on the CHAMPS-18 questionnaire;
  • Exclusion criteria:
  • Not medically stable by Greig criteria, and the medical history details in the ethics form
  • Conducting an active lifestyle
  • Skeletal muscle index (SMI) of ≥ 6.75 kg/m2 for women or ≥ 10.75 kg/m2 for men according to Janssen et al. (2003)
  • Cognitive impairment expressed as mini mental state examination (MMSE) score ≤
  • Current or recent (8 wk) use of fish-oil supplement intake
  • Current or recent (8 wk) use of proteins, vitamins or other supplements interfering the metabolic scope

排除标准

  • 未提供

结局指标

主要结局

Total and appendicular muscle mass

时间窗: Change from Baseline at day 84 & day 168

By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)

次要结局

  • Lower extremity physical function(Change from Baseline at day 84 & day 168)
  • Cognitive performance(Change from Baseline at day 84 & day 168)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brendan Egan

Lecturer in Sport and Exercise Science

University College Dublin

研究点 (2)

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