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临床试验/NCT07135388
NCT07135388已完成不适用

Treatment of Sarcopenia With Food for Special Medical Purposes in Rheumatologic Patients

University of Bari2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月31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
发起方
入组人数
15
试验地点
2
主要终点
Muscle mass

研究概览

简要总结

Sarcopenia is defined as a pathological condition related to muscle strength and muscle mass reduction. It is caused by ageing (primary sarcopenia) and diseases associated with systemic inflammation (secondary sarcopenia). Systemic inflammation in rheumatological diseases often leads to physical inactivity, which is the main predictor of sarcopenia in this pathological condition. In these patients, the treatment of sarcopenia must necessarily include an appropriate nutritional approach, and the addition of oral supplements should be considered a complementary approach.

详细描述

Sarcopenia is linked to two distinct pathogenetic mechanisms that often overlap: ageing (primary sarcopenia), and diseases associated with either systemic inflammation or impaired physical activity, or nutritional deficiencies (secondary sarcopenia). Some of the latter mechanisms are intimately connected since the pathway to sarcopenia often begins with a chronic disease that triggers systemic inflammation, leading to physical inactivity, as occurs in rheumatological diseases. Notably, in these patients, the reduction in physical activity leading to sarcopenia represents a prognostic indicator for potential complications and compromised quality of life.

Skeletal muscle trophism is influenced by hormone-like factors known as myokines, which are mainly secreted by muscles themselves, and by cytokines. Among these molecules, irisin, decorin, myonectin, myostatin, and interleukin-15 have been widely studied to develop pharmacological strategies to counteract sarcopenia.

In any case, the treatment of sarcopenia must necessarily include an appropriate nutritional approach that should consider both specific dietary components (dietary patterns) and nutrient intakes (total calories). As a matter of fact, specific dietary patterns are increasingly considered in nutritional studies on sarcopenia.

Currently, it has been observed that "high-quality diets" are associated with better physical functionality and a reduced risk of sarcopenia. However, although some nutrients and dietary patterns seem to have a potential protective effect against sarcopenia, in the presence of pathological conditions, the addition of oral nutritional supplements should offer the opportunity of adding high levels of specific nutritional components which are able to promote muscle trophism.

In this prospective longitudinal study, we evaluated the effect of a specific food for special medical purposes (FSMPs) supplementation on muscle strength, muscle mass, and muscle quality in rheumatologic patients with sarcopenia. In addition, we assessed myokine and cytokine variations in the serum, which are associated with this nutritional approach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Rheumatologic patients able to perform the handgrip test.

排除标准

  • •Upper limb arthropathy, chronic kidney disease with an eGFR <50 ml/min, severe congestive heart failure, cancer, decompensated diabetes, severe respiratory failure.

研究组 & 干预措施

Rheumatologic sarcopenic patients receiving high protein, high content of HMB oral supplement

Other

Patients received for three months an oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB)

干预措施: Food for special medical purposes (Dietary Supplement)

结局指标

主要结局

Muscle mass

时间窗: The interval between the beginning and the end of the single treatment was three months.

Muscle mass was assessed at time zero and after three months of oral supplementation by bioimpedance analysis

Muscle strength

时间窗: The interval between the beginning and the end of the single treatment was three months

Muscle strength was assessed at time zero and after three months of oral supplementation by a dynamometer

次要结局

  • Assessment of myokines and cytokines blood levels(The interval between the blood collection performed at the beginning and the end of the single treatment was three months)

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Barone

Associate Professor

University of Bari

研究点 (2)

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