跳至主要内容
临床试验/NCT03429491
NCT03429491已完成不适用

Novel Nutrition Solutions in Elderly at Risk of Sarcopenia: LC n-3 PUFA and Leucine Combinations

University College Dublin1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Appendicular skeletal muscle mass

研究概览

简要总结

This study will examine the effect of leucine-enriched protein supplementation, alone and in combination with long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), on muscle mass and function in older adults at risk of sarcopenia.

The investigators hypothesize that LC n-3 PUFA supplementation will further enhance the efficacy of the leucine-enriched protein.

详细描述

The progressive loss of skeletal muscle mass and function with advancing age, termed sarcopenia, contributes substantially to disability, physical dependence, and mortality among older adults. Aging is associated with an attenuated muscle protein synthetic response to the ingestion of small to moderate protein doses compared to younger persons. Several studies have reported that the acute, postprandial muscle protein synthesis (MPS) response to a suboptimal protein dose is enhanced when the leucine content of the protein bolus is increased. This indicates that supplementing the lower-protein daily meals (i.e., breakfast and lunch) with leucine may represent a practical strategy to augment the MPS response to these meals and, subsequently, attenuate sarcopenic muscle mass loss over time. In addition, LC n-3 PUFA supplementation has been shown to enhance the MPS response to amino acid infusion older adults suggesting that combined leucine and LC n-3 PUFA supplementation be particularly effective for improving daily MPS, muscle mass and function in older adults.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥65 y
  • Sex: males and females
  • Low muscle mass (assessed via bioelectrical impedance analysis using cut-offs from Janssen, 2004) and/or low handgrip strength (< 30 kg men, <20kg women)

排除标准

  • BMI >35 kg/m2
  • Cancer - malignancy in the past 5 years
  • Multiple Sclerosis, Parkinsons Disease
  • Chronic kidney disease
  • Liver failure
  • Conditions that will affect ability to consume, digest and/or absorb the study drink (i.e. cows milk protein allergy, inflammatory bowel disease)
  • Cognitive function < 21 on Mini-Mental State Examination
  • Excess alcohol intake
  • Regular resistance training
  • Total walking incapacity
  • Musculoskeletal or neuromuscular impairments that could interfere with strength testing
  • Medications interfering with muscle metabolism
  • Adherence to a high energy or high protein diet three months before starting and during the study. Use of protein containing or amino acid containing nutritional supplements three months before starting and during the study.
  • High consumers of oily fish.
  • Weight change > 3 kg past 3 months

研究组 & 干预措施

Placebo

Placebo Comparator

Protein-free, LC n-3 PUFA-free juice based supplement

干预措施: Placebo (Dietary Supplement)

Leucine-enriched protein

Experimental

Juice based supplement containing leucine-enriched protein

干预措施: Leucine-enriched protein (Dietary Supplement)

Leucine-enriched protein + LC n-3 PUFA

Experimental

Juice based supplement containing leucine-enriched protein and LC n-3 PUFA

干预措施: Leucine-enriched protein (Dietary Supplement)

Leucine-enriched protein + LC n-3 PUFA

Experimental

Juice based supplement containing leucine-enriched protein and LC n-3 PUFA

干预措施: LC n-3 PUFA (Dietary Supplement)

结局指标

主要结局

Appendicular skeletal muscle mass

时间窗: 6 months

Assessed via dual energy x-ray absorptiometry

次要结局

  • Muscle protein synthesis(6 months)
  • Thigh muscle mass(6 months)
  • Isometric knee extension strength(6 months)
  • Physical performance(6 months)
  • Metabolomics(6 months)
  • Transcriptomics(6 months)

研究者

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

Prof Helen M Roche

Professor Helen Roche

University College Dublin

研究点 (1)

Loading locations...

相似试验

Novel Nutrition Solutions for Sarcopenia | 临床试验