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临床试验/NCT04701463
NCT04701463已完成不适用

Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women

Azienda di Servizi alla Persona di Pavia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Changes on Visceral Adipose Tissue

研究概览

简要总结

The use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (FSMP) for muscle recovery, consisting of arginine, glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopause
  • Obesity (I class) or overweight

排除标准

  • Taking any medication
  • Having liver, renal and thyroid disease
  • Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

结局指标

主要结局

Changes on Visceral Adipose Tissue

时间窗: Baseline / 30 days

Evaluation of Visceral Adipose Tissue (g)

次要结局

  • Changes on Body Composition(Baseline / 30 days)
  • Changes on skin condition(Baseline / 30 days)
  • Changes on Metabolic parameters(Baseline / 30 days)
  • Changes on anthropometric measurements(Baseline / 30 days)

研究者

发起方
Azienda di Servizi alla Persona di Pavia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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