Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Lean weight
研究概览
简要总结
Sarcopenia is a progressive and generalised skeletal muscle disorder involving the accelerated loss of muscle mass and function that is associated with increase adverse outcomes including falls, functional decline, frailty and mortality. Diet, specifically protein has been proposed to have a role in the prevention and treatment of muscle loss in the older adult population nevertheless there is paucity of research on the effect of protein supplementation on lean body mass and other clinical outcomes in older adults.
This 2-arm parallel, double-blind, randomised, controlled dietary supplement human intervention study aims to investigate the effect of consuming 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily in combination with exercise for 8 weeks on whole body lean mass tissue and measures of muscle strength and functionality in free living community dwelling older adults.
Participants (N150; 75/site (Ulster & Limerick); 75/group; 50-70 years) will be stratified by age, gender and BMI and randomly allocated to consume two sachets of either the Blue Whiting Protein Hydrolysates powder daily (12.5g at breakfast and lunch (Total 25g)), (mixed with an everyday food / drink product (provided by Ulster University) or an isocalorific maltodextrin citrus flavoured powder (Control) (mixed with an everyday food / drink product).
Assessments to be undertaken pre and post intervention include; body composition including lean tissue mass measured by DXA whole body scan (Ulster site only), Bio-Electrical Impedance Analysis (BIA), hand grip strength, a 'timed get up and go' test, 6 minute walk test, gait speed test, chair stand test, blood pressure measurements, a quality of life questionnaire, a health and lifestyle questionnaire and a physical activity questionnaire. A trained phlebotomist will obtain a 40ml max blood sample from each participant pre and post intervention. Blood samples will be used to measure markers associated with sarcopenia (serum 25(OH)D, pro inflammatory cytokine profile, full lipid profiles and kidney and liver profiles). A 4-day food diary will be collected at baseline only to determine habitual protein intake. At post intervention only, bone mineral density at the spine and hip will be measured by a DXA scanner.
Comparisons will be made (ANCOVA) between the intervention group and control group over time.
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)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Free-living, apparently healthy older adults
- •Able to fast from 10pm prior to the appointment
- •Aged 50-70 years at recruitment
- •Not regularly taking protein supplements
- •Free from serious musculoskeletal injury
排除标准
- •Adults <50 years at recruitment
- •Food allergy or intolerance that would prevent consumption of fish
- •Diagnosed with any form of terminal disease or past medical history of conditions or medications that may interfere with supplementation and/or study outcomes, such as diabetes, kidney, digestive, thyroidal disease
- •Cognitive impairment
- •Exclusively receiving enteral or parenteral nutrition
- •Currently taking any protein supplement
- •Undertaking resistance exercise regularly
- •Planning to lose weight/go on a special diet
- •Any conditions/anomalies that could potentially interfere with the DXA
- •Been advised not to undertake physical activity
结局指标
主要结局
Lean weight
时间窗: Change over 8 weeks
Measured by Bio-Electrical Impedance Analysis
次要结局
- Exercise tolerance(Change over 8 weeks)
- Muscle strength(Change over 8 weeks)
- Walking speed(Change over 8 weeks)
- Mobility(Change over 8 weeks)
- Blood pressure(Change over 8 weeks)
- Functional fitness(Change over 8 weeks)
- Lean weight(Change over 8 weeks)