Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 主要终点
- Total weight loss, in percentage, from baseline to end-of-treatment
研究概览
简要总结
BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is associated with obesity development. In this regard, those subject with the preference for evening seems to be prone to develop obesity. However, the current treatment of obesity does not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to patient's chronotype is more effective than the current dietary recommendations.
SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104 subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105 subjects undergone a diet with a daily caloric distribution adjusted to their chronotype (CHRONO).
CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness regarding weight loss when the diet was adjusted to the patient's chronotype.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old
排除标准
- •clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer)
- •those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.)
- •women in special physiological situations (pregnant, lactating).
结局指标
主要结局
Total weight loss, in percentage, from baseline to end-of-treatment
时间窗: 12 weeks
Percentage of weight loss, measured with a scale, from baseline weight (100% body weight) since body weight after 12 weeks of treatment (final body weight). Percentage of body weight was then measured as Total Weight Loss (%) = (Final body weight - Baseline body weight) / baseline body weight x 100.
次要结局
- Anthropometrical and other clinical parameters(12 weeks)
- BMI loss(12 weeks)
研究者
Juan Jose Hernández Morante
Principal Investigator of Eating Disorders Research Unit
Universidad Católica San Antonio de Murcia