The CLOCK Study - A Human Dietary Intervention Study on Peripheral Circadian Clocks and Energy Metabolism
- Conditions
- Metabolic Response to Dietary Modification
- Interventions
- Other: Carbohydrate-rich (HC)Other: Fat-rich (HF)
- Registration Number
- NCT02487576
- Lead Sponsor
- German Institute of Human Nutrition
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Carbohydrate-rich_Fat-rich (HC_HF) Carbohydrate-rich (HC) 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 Carbohydrate-rich_Fat-rich (HC_HF) Fat-rich (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) Carbohydrate-rich (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 Fat-rich_Carbohydrate-rich (HF_HC) Fat-rich (HF) 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
- Primary Outcome Measures
Name Time Method Dietary-induced changes of glucose and lipid metabolism week 4 Effect of different diurnal patterns of meal composition on peripheral circadian clocks in blood cells and subcutaneous adipose tissue week 4
- Secondary Outcome Measures
Name Time Method Dietary-induced changes of satiety and hunger scores week 4 Measured via visual analogue scales
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 Microarray Analysis of adipose tissue samples
Trial Locations
- Locations (1)
German Institute of Human Nutrition
🇩🇪Potsdam-Rehbruecke, Nuthetal, Germany