The Safety and Effects on Whole Organism of Low Energy Ketogenic Diet for Weight Loss in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in body composition
研究概览
简要总结
The study evaluates the timeline of changes of body composition, physical and psychological performance, and biochemical markers of metabolism and inflammation responses to low energy ketogenic diet for loosing weight in obese individuals. The participants will be monitored and guided by the interdisciplinary obesity team for 12 weeks.
详细描述
Ketogenic diets have been shown to be an effective tool to fight obesity with reported good adherence due to their ability to suppress the drive to eat. They are also gaining popularity in public, despite some concerns regarding the quality and timeline of changes of body composition and the effects on health parameters of whole organism.
For effective weight loss, energy deficit is required. Very low energy (600 - 800 kcal) ketogenic diets have been extensively studied.
The proposed study combines low energy (800 - 1500 kcal) and ketogenic diet intervention. The aim of the study is a comprehensive determination of quality of body mass loss, metabolic states changes, physical and psychological performance changes, and inflammatory and hormones profile changes during and post a 12-week low energy ketogenic diet intervention.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 kg/m2
- •asymptomatic for any disease except obesity
排除标准
- •presence of cardiovascular, endocrine, acute or chronic inflammatory diseases;
- •taking medications for lipid metabolism, or psychiatric disorders;
- •adherence to a prescribed diet;
- •unstable weight in the past 3 months;
- •BMI < 30 kg/m2;
- •unwilling or unable to eat the foods prescribed in the study;
- •vigorous physical activity;
- •pregnancy or lactation.
研究组 & 干预措施
participants
The participants will be subjected to low energy ketogenic diet.
干预措施: Low energy ketogenic diet (Behavioral)
结局指标
主要结局
Change in body composition
时间窗: Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Body mass, fat free body mass and fat mass will be measured (all in kilograms) with bioelectrical impedance analysis (BIA) Tanita BC 418MA.
Change in beta-hydroxybutirate
时间窗: Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Overnight fasted serum beta-hydroxybutirate will be determined (in mmol/l).
Change in resting energy rate
时间窗: Change from baseline to 12 weeks.
Resting energy rate will be determined with indirect calorimetry.
Change in physical fitness
时间窗: Change from baseline to 12 weeks.
Physical fitness will be determined using 2 km walking test according to the UKK Walk Test Programme.
Change in cognitive functions
时间窗: Change from baseline to 12 weeks.
Will be assessed by validated psychological test (Wechsler Adult Intelligence Scale - Forth Edition (WAIS-IV).
Change in psychological factors
时间窗: Change from baseline to 12 weeks.
Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).
次要结局
- Change in body weight following intervention(Change from 12 weeks to 12 months.)
- Adherence to ketogenic diet(At 12 months.)
研究者
Zala Jenko Praznikar
Assist. prof. dr. sc.
University of Primorska