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临床试验/NCT05287659
NCT05287659已完成不适用

Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月3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
50
试验地点
2
主要终点
Body weight

研究概览

简要总结

The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important challenges to public health and national health care system, especially during the COVID pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition and proper physical activity is essential to counteract SO progression. In accordance with the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. Recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases.

To date, the effects of physical training during VLCKD have not been studied. The aim is to determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD alone, on weight-loss, body composition and physical performance in patient with SO.

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
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • obesity (BMI 30-40)
  • FAT MASS % ( > 41% for W, >29% for M)
  • HOMA-IR > 2,5

排除标准

  • known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery

结局指标

主要结局

Body weight

时间窗: Body weight will be calculated at baseline and after 45 days

Body weight change from baseline

次要结局

  • Body Mass Index(Body Mass Index will be calculated at baseline and after 45 days)
  • Fat Mass(Fat Mass will be calculated at baseline and after 45 days)
  • Fat Free Mass(Fat Free mass will be calculated at baseline and after 45 days)
  • Fasting glucose(Fasting glucose will be calculated at baseline and after 45 days)
  • Fasting insulin(Fasting insulin will be calculated at baseline and after 45 days)
  • Muscle strength(Muscle strength will be calculated at baseline and after 45 days)
  • Physical Performance assessed by Short Physical Performance Battery (SPPB)(SPPB will be calculated at baseline and after 45 days)

研究者

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

Lucio Gnessi

Lucio Gnessi

University of Roma La Sapienza

研究点 (2)

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