Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
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
- 否
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
Lucio Gnessi
Lucio Gnessi
University of Roma La Sapienza
