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临床试验/NCT07754760
NCT07754760已完成不适用

Essential Amino Acid Supplementation Enhances Post-prandial Amino Acid Availability Following a Standard-protein Breakfast in Older Adults: a Randomised Crossover Trial

Leeds Beckett University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年6月17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
10
试验地点
1
主要终点
Plasma amino acid concentration

研究概览

简要总结

Healthy older adults and those who have acute and chronic conditions suffer from reduced protein intake and are at risk of developing both chronic and acute sarcopenia. Amino acid supplementation can provide appropriate conditions for muscle protein synthesis to occur. However, the exact amino acid ratio that may optimise this is currently unknown. The purpose of this crossover trial is to compare different amino acid gels and identify which results in the greatest concentration of plasma amino acids following a standardised breakfast. This will allow development of management strategies for healthy and diseased populations who suffer from reduced protein intake.

详细描述

Sarcopenia refers to a skeletal muscle disorder via loss of muscle strength, mass and function that naturally progresses with age. More recently however, the phenomenon of acute sarcopenia (AS) has been suggested which refers to sarcopenia that occurs within a period of six months. This rapid deterioration of muscle, which typically occurs as a result of an illness or stressor, significantly increases the risk of hospital admission, loss of independence, and mortality making it an important target for future research.

Poor nutrition and specifically inadequate energy and dietary protein intakes are contributors to the development of both sarcopenia and AS. Therefore, addressing energy and protein deficiencies have been proposed in review papers as a means to prevent and/or better manage sarcopenia and AS. This is not something that has been explicitly investigated within this specific clinical population to date. Nutritional interventions which are focused on addressing total energy and protein deficiencies will optimise skeletal muscle adaptations via essential amino acids, particularly Leucine, found in protein acting as an important anabolic stimulus for the mammalian target of rapamycin (mTOR). Therefore, this type of management strategy should be able to attenuate the muscle wasting and exacerbated life outcomes (mortality, loss of independence, frailty) that occurs in AS and among other serious health conditions.

Older populations require approximately 30-40g of protein per meal ( ̴0.45 g/kg/BM/Day), with particular importance of leucine, in order to achieve recent recommended daily amounts of 1.2-1.6g/kg/BM/day but this is difficult to achieve in the older population which naturally suffers from a reduced appetite and increased perception of fullness. Breakfast and lunch commonly suffer from the greatest deficiency in protein intake and Ispoglou et al. have developed effective ways in which to increase dietary protein intake without affecting hunger.

The gels which Ispoglou et al. have developed contain 7.5g of essential amino acids (EAAs) per sachet of 65 ml volume each, the equivalent found in 15g of high-quality protein (3g of leucine), and the addition of one of these gels alongside a meal could potentially assist older adults to reach optimal protein requirements on a per meal and daily basis. Previously, supplementation with EAAs has shown to be effective in increasing functional performance and lean tissue mass, while it has been proposed as a potential nutritional therapy for addressing sarcopenia. These EAA gels also do not affect appetite in older adults and have been shown to be an effective means for enhancing both protein and energy intake in older adults.

Supplementation with such gels, as we have shown, can increase plasma concentrations of essential amino acids (AAs), such as leucine, which in turn can act as anabolic stimuli and enhance muscle protein synthesis and potentially prevent or minimise muscle wasting. Plasma concentrations of amino acids, in particular leucine, drives muscle protein synthesis however an excessive concentration of leucine can increase oxidation rates of other essential amino acids, in particular L-isoleucine and L-valine, meaning there is lower plasma availability for muscle protein synthesis. Thus, it is important to identify which AA ratio can maximise the potential for muscle protein synthesis rather than increase oxidation of AAs and limit muscle protein synthesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •60 years or older
  • •Able and willing to provide written informed consent for the study
  • •Capable of ingesting the oral supplement

排除标准

  • •Incapable of understanding the study and providing informed consent
  • •Incapable of ingesting the oral supplement
  • •Any known cardiovascular disease
  • •Any known kidney problems or requiring dialysis treatment
  • •Any known health issue which may affect the uptake and concentration of plasma amino acids
  • •Suffer from coeliac disease
  • •Being allergic to any of the ingredients in the supplements or standardised breakfast (e.g., nuts and/or oats, wheat, barley, soya)
  • •Lactose intolerant

研究组 & 干预措施

Gel A

Active Comparator

An essential amino acid supplement based on Ispoglou et al. (2016; 2017)'s previous work.

干预措施: Essential amino acid supplement (Dietary Supplement)

Gel B

Active Comparator

An essential amino acid supplement based on Kobayashi et al. (2010)'s previous work.

干预措施: Essential amino acid supplement (Dietary Supplement)

Placebo

Placebo Comparator

An energy matched placebo containing no amino acids.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Plasma amino acid concentration

时间窗: Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.

A series of blood samples collected prior to and post-supplementation were assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to accurately quantify the plasma concentrations of 15 amino acids. This allowed individual amino acid analysis as well as grouped analysis of non-essential, essential, and branched-chain amino acids.

次要结局

  • Appetite(Baseline (pre-supplementation), 15 minutes post-supplementation, and every 30 minutes thereafter for the following 3-hours.)
  • Palatability(Immediately post-supplementation)

研究者

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

Antonis Stavropoulos-Kalinoglou

Reader

Leeds Beckett University

研究点 (1)

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