PROMOTe 研究：用益生元靶向肠道微生物组以克服与年龄相关的合成代谢抵抗：一项双盲、随机、安慰剂对照试验的方案。
The PROMOTe study: targeting the gut microbiome with prebiotics to overcome age-related anabolic resistance: protocol for a double-blinded, randomised, placebo-controlled trial.
机构信息
Department of Twin Research & Genetic Epidemiology, King's College London, 3rd Floor South Wing, St Thomas' Hospital, SE1 7EH, London, UK.
Department of Nutritional Sciences, King's College London, London, UK.
出版信息
BMC Geriatr. 2021 Jul 1;21(1):407. doi: 10.1186/s12877-021-02301-y.
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 anabolise muscle in response to protein supplementation as well as younger people, so called 'anabolic resistance'. The aetiology and molecular mechanisms for this are not understood, however the gut microbiome is known to play a key role in several of the proposed mechanisms. Thus, we hypothesise that the gut microbiome may mediate anabolic resistance and therefore represent an exciting new target for ameliorating muscle loss in older adults. This study aims to test whether modulation of the gut microbiome using a prebiotic, in addition to protein supplementation, can improve muscle strength (as measured by chair-rise time) versus protein supplementation alone.
METHODS
The study is a randomised, double-blinded, placebo-controlled trial, with two parallel arms; one will receive prebiotic and protein supplementation, and the other will receive placebo (maltodextrin) and protein supplementation. Participants will be randomised as twin pairs, with one twin from each pair in each arm. Participants will be asked to take supplementation once daily for 12 weeks in addition to resistance exercises. Every participant will receive a postal box, containing their supplements, and the necessary equipment to return faecal, urine, saliva and capillary blood samples, via post. A virtual visit will be performed using online platform at the beginning and end of the study, with measures taken over video. Questionnaires, food diary and cognitive testing will be sent out via email at the beginning and end of the study.
DISCUSSION
This study aims to provide evidence for the role of the gut microbiome in anabolic resistance to dietary protein. If those who take the prebiotic and protein supplementation have a greater improvement in muscle strength compared with those who take protein supplementation alone, this would suggest that strategies to modify the gut microbiome may reduce anabolic resistance, and therefore potentially mitigate sarcopenia and frailty in older adults.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT04309292 . Registered on the 2nd May 2020.
背景
随着年龄的增长，骨骼肌质量和力量会逐渐减少，这与功能丧失、残疾以及肌肉减少症和虚弱的发展有关。膳食蛋白质对骨骼肌功能至关重要，但老年人对蛋白质补充的肌肉合成作用不如年轻人，这被称为“合成代谢抵抗”。目前尚不清楚这种现象的病因和分子机制，但已知肠道微生物组在几个提出的机制中起着关键作用。因此，我们假设肠道微生物组可能介导合成代谢抵抗，因此代表了改善老年人肌肉减少的一个令人兴奋的新靶点。本研究旨在测试使用益生菌调节肠道微生物组，除了蛋白质补充外，是否可以改善肌肉力量（以椅子起身时间衡量），而不仅仅是蛋白质补充。
方法
该研究是一项随机、双盲、安慰剂对照试验，有两个平行组；一组将接受益生菌和蛋白质补充，另一组将接受安慰剂（麦芽糊精）和蛋白质补充。参与者将作为双胞胎进行随机分组，每组双胞胎中的一个在每个组中。参与者将被要求每天补充一次，持续 12 周，同时进行抗阻运动。每位参与者将通过邮寄获得一个邮箱，其中包含他们的补充剂和必要的设备，以通过邮寄返回粪便、尿液、唾液和毛细血管血样。在研究开始和结束时，将使用在线平台进行虚拟访问，并通过视频进行测量。在研究开始和结束时，将通过电子邮件发送问卷、食物日记和认知测试。
讨论
本研究旨在为肠道微生物组在膳食蛋白质的合成代谢抵抗中的作用提供证据。如果服用益生菌和蛋白质补充剂的人在肌肉力量方面的改善程度大于仅服用蛋白质补充剂的人，这表明改变肠道微生物组的策略可能会减少合成代谢抵抗，从而潜在地减轻老年人的肌肉减少症和虚弱。
试验注册
Clinicaltrials.gov：NCT04309292。于 2020 年 5 月 2 日注册。
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