Interplay of Peripheral Circadian Clocks With Energy Balance and Body Weight Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Dietary-induced changes of glucose and lipid metabolism
研究概览
简要总结
This human dietary intervention study with a cross-over design aims to investigate the effect of two different diurnal patterns of meal composition on peripheral circadian clocks and energy metabolism in healthy men.
详细描述
In this cross-over study, healthy male participants are randomly allocated to one of two study groups: In study group (A) participants consume isocaloric carbohydrate-rich meals (65% Carbohydrates; 20% Fat; 15% Protein) in the morning and fat-rich meals (35% Carbohydrate; 50% Fat; 15% Protein) in the evening for four weeks. After a washout-phase participants consume isocaloric fat-rich meals in the morning and carbohydrate-rich meals in the evening for another four weeks. Study group (B) receives the same interventions in the reversed order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 22 kg/m² and 34,9 kg/m²
- •Normal glucose tolerance determined in a 75g-oral glucose tolerance test
- •Impaired fasting glucose determined in a 75g-oral glucose tolerance test
- •Impaired glucose tolerance determined in a 75g-oral glucose tolerance test
排除标准
- •Shift workers or history of shift work
- •Men suffering from diseases or conditions that might influence the outcome of the study. Of special interest are diseases that influence body weight regulation (enteropathy, malabsorption, hepatopathy, renal disease, endocrine disorders, diabetes mellitus, eating disorders, heart disease etc.). Also men suffering from coagulopathy, apoplexy and myocardial infarction are excluded from the study.
- •Men suffering from psychiatric disease
- •Planned changes in physical activity during the study
- •Participation in other clinical studies within the last three months
- •Weight changes > 2 kg within 2 months prior to screening day
- •Men unable to give an informed consent
- •Men unable to engage in the dietary interventions
- •Men following a special diet
研究组 & 干预措施
Carbohydrate-rich_Fat-rich (HC_HF)
Isocaloric carbohydrate-rich meals in the morning (06.00 am - 01.30 pm) and isocaloric fat-rich meals in the evening (04.30 pm - 10.00 pm) for 4 weeks
Fat-rich_Carbohydrate-rich (HF_HC)
Isocaloric fat-rich meals in the morning (06.00 am - 01.30 pm) and isocaloric carbohydrate-rich meals in the evening (04.30 pm - 10.00 pm) for 4 weeks
干预措施: Carbohydrate-rich (HC) (Other)
Fat-rich_Carbohydrate-rich (HF_HC)
Isocaloric fat-rich meals in the morning (06.00 am - 01.30 pm) and isocaloric carbohydrate-rich meals in the evening (04.30 pm - 10.00 pm) for 4 weeks
干预措施: Fat-rich (HF) (Other)
结局指标
主要结局
Dietary-induced changes of glucose and lipid metabolism
时间窗: week 4
Effect of different diurnal patterns of meal composition on peripheral circadian clocks in blood cells and subcutaneous adipose tissue
时间窗: week 4
次要结局
- Dietary-induced changes of satiety and hunger scores(week 4)
- Effect of different diurnal patterns of meal composition on Lipopolysaccharide-induced cytokine expression(week 4)
- Dietary-induced changes of the human adipose tissue lipidome(week 4)
- Integrative analysis of dietary-induced changes of the human adipose tissue transcriptome(week 4)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Prof. Dr. med Andreas F.H. Pfeiffer
German Institute of Human Nutrition