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临床试验/NCT04001907
NCT04001907Unknown不适用

Effects of β-hydroxy-β-methyl Butyrate Supplementation and Resistance Exercise on Body Composition, Muscle Strength and Protein Oxidation in Sickle Cell Anaemia.

The University of The West Indies0 个研究点目标入组 24 人开始时间: 2013年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Body composition assessment using deuterium dilution method

研究概览

简要总结

Wasting is a common and significant problem in sickle cell anaemia (SCA) that correlates with poorer clinical outcome such as frequent painful crises, acute chest syndrome and sub normal resistance to infection. Thus, improvement of nutritional status in SCA holds the potential of ameliorating the course of the disease. Elevated haemolysis and its effects are associated with hypermetabolism and have resulted in higher rates of protein breakdown and synthesis, and energy expenditure. Offering more food has not optimized nutritional status and metabolic performance in free-living patients with SCA. Moreover, appetite might be suppressed. Supplementation with β-hydroxy-β-methylbutyrate (HMB), which is produced in the body from leucine, has been shown to have inhibitory effect on protein breakdown and to promote lean tissue synthesis in humans with sarcopenia. Also, HMB has been implicated as an ergogenic tool to promote exercise performance and skeletal muscle hypertrophy. Therefore, the investigators hypothesize that in individuals with SCA, an intervention of resistance exercise with HMB supplement will have a greater enhancing effect on muscle mass and strength compared to receiving resistance exercise without HMB.

详细描述

The investigators aim to measure muscle strength, body composition and whole body protein oxidation in two groups of adults with SCA within one week before and after 9 weeks of intervention in a randomized, double blinded study. One group (n =12 ) will receive an intervention of resistance exercise and HMB supplement, and the other group (n=12) will receive resistance exercise and a placebo (maltodextrin). Participants will be assigned a study code and all information and samples will be stored under the assigned code.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 18.5 kg/m2

排除标准

  • BMI > 19 kg/m2

研究组 & 干预措施

exercise combined with β-hydroxy-β-methylbutyrate (HMB)

Experimental

Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks

干预措施: Resistance exercise (Behavioral)

exercise combined with β-hydroxy-β-methylbutyrate (HMB)

Experimental

Resistance Exercise ( 3d/week) and HMB: 3g/d as three 1g capsules orally, for 9 weeks

干预措施: β-hydroxy-β-methylbutyrate (Dietary Supplement)

exercise combined with placebo

Placebo Comparator

Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks

干预措施: Resistance exercise (Behavioral)

exercise combined with placebo

Placebo Comparator

Resistance exercise ( 3d/week) and placebo as 3g/d maltodextrin as three 1g capsules orally, for 9 weeks

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

Body composition assessment using deuterium dilution method

时间窗: 3 months

Change between baseline and after 3 months of intervention

Body composition assessment using Dual-energy X-ray absorptiometry

时间窗: 3 months

Change between baseline and after 3 months of intervention

Body composition assessment using bioelectrical impedance

时间窗: 3 months

Change between baseline and after 3 months of intervention

muscle strength assessment using the 1-repetition maximum method for the lower body (leg extension and or seated leg press) and upper body (bench press, bicep preacher curl)

时间窗: 3 months

Change between baseline and after 3 months of intervention

Protein oxidation using established stable isotope tracer method with oral doses of isotopically labelled sodium bicarbonate and phenylalanine

时间窗: 3 months

Change between baseline and after 3 months of intervention

次要结局

  • Dietary intake using three 24 h dietary recall before and after intervention(30 min)
  • Resting metabolic rate using indirect calorimetry before and after intervention(30 min)

研究者

申办方类型
Other
责任方
Sponsor

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