Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Body weight regain
研究概览
简要总结
Low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. Yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies.
The aim of this study is to determine the effect of a low-carbohydrate (CHO) ketogenic diet, compared with an isocaloric balanced diet, on the maintenance of weight loss. The secondary aim is to investigate the impact of both diets on appetite. Adults with obesity (30<BMI<40 kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight loss and then will be randomized to two different weight maintenance diets for 1 year. One will be a low-CHO ketogenic diet (50 g CHO/day) plant-based (e.g. with less animal protein and more plant-based), and the other a diet following the Norwegian Health Directorate recommendations. Only conventional foods will be used in both diets.
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
- Single (Participant)
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
- •weight stable over the last three months (<2 kg)
- •not currently dieting to lose weight
- •inactive lifestyle (less than 150 min of physical activity weekly.
- •Given that some of the variables of interest have been shown to be affected by the phase of menstrual cycle in normally ovulating women, namely appetite and resting metabolic rate, only women taking oral contraceptives, with regular menstrual cycles or post-menopausal will be included in the study
排除标准
- •pregnancy
- •breast-feeding
- •drug or alcohol abuse within the last two years
- •clinically significant illness including diabetes, gastrointestinal (particularly cholelithiasis), kidney (GFR <60) or liver disease, osteoporosis (T-score <-2.5) and osteopenia (T-score <-1.5)
- •treatment with antiosteoporotic drug
- •depression or other psychological disorders
- •eating disorders
- •milk intolerance
- •current medication known to affect appetite/metabolism or induce weight loss.
- •a planned surgery during the study period
- •participating in another research study
结局指标
主要结局
Body weight regain
时间窗: Body weight changes at 1-year intervention
Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year
次要结局
- Fasting lipid profile(Lipid profile changes at 1-year intervention)
- Bone mineral density(Bone mineral density changes at 1-year intervention)