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临床试验/NCT03299972
NCT03299972已完成不适用

Effects of 12 Weeks Resistance Exercise and Whey Protein Supplementation on Energy Metabolism, Appetite, Body Composition and Biomarkers Related to Sarcopenia and Metabolic Health

Coventry University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年10月27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
39
试验地点
2
主要终点
Changes in 24-h substrate oxidation (g/d)

研究概览

简要总结

The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance.

Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

详细描述

With demographics indicating that the world's population aged >60 years will increase from 600 million reported in 2000, to >2 billion by 2050, there is an increasing interest in health issues related to ageing. One area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. Studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). However, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. This randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.

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
60 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Retired Men aged 60-80 years
  • Body Mass Index 18.5-30 kg/m2
  • Not participated in resistance exercise within the last 6 months
  • Free from musculoskeletal injury

排除标准

  • Retired Men aged <60 or >80 years
  • Current smokers, or ex-smokers ceasing <6 months ago
  • Body Mass Index <18.5 and >30 kg/m2
  • Currently participating in resistance exercise regularly (within last 6 months)
  • Not weight stable and/or looking to start a weight loss programme
  • Individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention
  • Existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or history of falls
  • Currently taking protein/amino acid supplements regularly
  • Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (HRT), diabetic medication, beta-blockers, statins
  • Uncontrolled blood pressure (Blood pressure >160/100 mmHg)
  • Self-reported lactose intolerant or allergic to wheat or potatoes
  • Individuals with a pacemaker
  • Neuromuscular disorders or injuries

研究组 & 干预措施

Whey Protein

Experimental

干预措施: Whey Protein (Dietary Supplement)

Control

Placebo Comparator

干预措施: Control (Dietary Supplement)

Resistance Exercise + Control

Experimental

干预措施: Control (Dietary Supplement)

Resistance Exercise + Control

Experimental

干预措施: Resistance Exercise (Other)

Resistance Exercise + Whey Protein

Experimental

干预措施: Resistance Exercise (Other)

Resistance Exercise + Whey Protein

Experimental

干预措施: Whey Protein (Dietary Supplement)

结局指标

主要结局

Changes in 24-h substrate oxidation (g/d)

时间窗: 0 to 12 weeks

Measured by whole-room calorimetry

Changes in components of 24-h energy expenditure and its components (kcal/d)

时间窗: 0 to 12 weeks

Measured by whole-room calorimetry

Changes in body composition (kg)

时间窗: 0 to 12 weeks

Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis

次要结局

  • Biochemical: Appetite hormones(0 to 12 weeks)
  • Isotonic Strength (kg) - Leg press and leg extension(0 to 12 weeks)
  • Biochemical: Myostatin(0 to 12 weeks)
  • Biochemical: Inflammtion(0 to 12 weeks)
  • Interstitial Glucose(0 to 12 weeks)
  • Biochemical: Insulin Resistance (HOMAR-IR)(0 to 12 weeks)
  • Salivary:Diurnal Cortisol(0 to 12 weeks)
  • Biochemical: Insulin-Like Growth Factor 1 (IGF-1)(0 to 12 weeks)
  • Handgrip strength (kg)(0 to 12 weeks)
  • Endurance (Six Minute Walk Test)(0 to 12 weeks)
  • Short Physical Performance Battery (SPPB)(0 to 12 weeks)
  • Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery(0 to 12 weeks)
  • Habitual Physical Activity(0 to 12 weeks)

研究者

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

Corbin Griffen

Principle Investigator

Coventry University

研究点 (2)

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