Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- measure of energy expenditure
研究概览
简要总结
This study aimed at evaluating the effectiveness of the active phase of a very low-calorie ketogenic diet in females with obesity lasting 28 days on body weight, body composition and energy metabolism using a metabolic chamber.
详细描述
Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa. Enrolled subjects underwent active phase of very low-calorie ketogenic diet within the metabolic chamber from day 0 for a duration of 4 weeks (day 0-28). On days 0, 7, and 28, patients underwent a 24-hour measurement of energy metabolism using the metabolic chamber. On the day of exit from the chamber measurement of body composition was conducted using total-body densitometry (Lunar iDXA; GE Healthcare).
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
- 是
入选标准
- •overweight and obesity
排除标准
- •Type 1 and type 2 diabetes mellitus
- •endocrine disorders
- •asthma or pulmonary conditions
- •cardiovascular disease
- •gastrointestinal disease
- •liver disease
- •kidney diseases
- •anemia (hemoglobin < 11 g/dL)
- •leucopenia (white blood cells < 4,000/mcL)
- •thrombocytopenia (platelets < 150,000/mcL)
- •central nervous system disorders
- •neurodegenerative diseases
- •psychiatric disorders
- •eating disorders
- •alcohol abuse and substance dependence
- •pregnancy
- •lactation.
结局指标
主要结局
measure of energy expenditure
时间窗: 1 month
measures of energy expenditure (in kilocalories) will be assessed by using the metabolic chamber, 24-hour whole room indirect calorimeter. Thus, the measures will be expressed in Kilocalories over 24 hours.
次要结局
未报告次要终点
研究者
Alessio Basolo
Researcher, PhD, MD
University of Pisa