Dietary Protein and Skeletal Muscle in Older Twins - Targeting the Gut Microbiome to Overcome Anabolic Resistance: The PROMOTe Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in chair rise time
研究概览
简要总结
Research Question: Does the gut microbiome contribute to muscle anabolic resistance to protein supplementation in older adults?
Background: Loss of muscle occurs with age and skeletal muscle in older adults can display anabolic resistance to protein in diet. It has been hypothesised that the gut microbiome may play a role in this relationship and therefore could be targeted.
Aim:
This trial aims to test whether modulation of the gut microbiome, in addition to protein supplementation, can improve skeletal muscle function versus protein supplementation alone.
Methods:
Double blinded, randomised, placebo controlled, dietary intervention study. Twin pairs will be randomised to either receive protein supplementation plus placebo or protein supplementation plus a gut microbiome modulator (prebiotic plus probiotic) for 12 weeks. Primary outcome will be muscle function measured using chair-rise time.
Conclusion:
Anabolic resistance warrants further characterisation to guide future therapeutic interventions, especially considering its role in the development of disability, sarcopenia and frailty.
详细描述
Research Question: Does the gut microbiome contribute to muscle anabolic resistance to protein supplementation in older adults?
Background: Loss of skeletal muscle mass and strength occurs with increasing age and is associated with loss of function, disability, and the development of sarcopenia and frailty. Dietary protein is essential for skeletal muscle function, but older adults do not respond as well as younger people to protein, so called 'anabolic resistance'. The aetiology and molecular mechanisms for this are not understood, however a number have been proposed. The gut microbiome is known to play a key role in a number of these postulated mechanisms. This has led us to hypothesise that the gut microbiome may mediate anabolic resistance and could represent an exciting new target for ameliorating muscle loss in older adults.
Aim:
This trial aims to test whether modulation of the gut microbiome, in addition to protein supplementation, can improve skeletal muscle function versus protein supplementation alone.
Methods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged >=60 years
- •Dietary protein intake of <1.3g/kg/day
- •Able to consent
- •Able to access video calls on a device such as laptop/tablet
排除标准
- •Severe food allergy
- •Current or recent antibiotic use (preceding 3 months)
- •Currently or recent use of protein or leucine supplements (preceding 3 months)
- •Currently or recent use of probiotic or prebiotic food supplements (preceding 3 months)
- •Current or prior history of gastrointestinal disease e.g. gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome
- •history of any significant injury or surgery which currently affects physical functioning and ability to undertake chair stand test
- •weight loss of ≥5% of body weight in preceding 6-12 months
- •Currently involved in other intervention studies
- •Any condition or circumstance likely to interfere with the normal conduct of the study and interpretation of the results, as judged by the investigators As the study population are over 60 years old, it is assumed that there will be no pregnant women who are eligible to take part.
结局指标
主要结局
Change in chair rise time
时间窗: baseline and end of study (12 weeks)
Chair rise time refers to the time it takes to complete 5 chair rises, without using arms. It is a well-recognised proxy marker of muscle strength. The change from baseline chair rise time at 12 weeks is the primary outcome. The residuals of change will be used in analysis.
次要结局
- Gripstrength, as measured by dynamometer(baseline and end of study (12 weeks))
- Microbiome composition(baseline and end of study (12 weeks))
- Questionnaire measures: appetite as measured by SNAQ(baseline and end of study (12 weeks))
- Questionnaire measures: physical activity as measured by IPAQ(baseline and end of study (12 weeks))
- Salivary microbiome(baseline and end of study (12 weeks))
- Urinary microbiome(baseline and end of study (12 weeks))
- Anthropological measures: height(baseline and end of study (12 weeks))
- Anthropological measures: weight(baseline and end of study (12 weeks))
- Metabolites in serum(baseline and end of study (12 weeks))
- Cognition(baseline and end of study (12 weeks))