Metabolic Response to Dietary Modification
Conditions
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.
Interventions
OTHERCarbohydrate-rich (HC)
65% Carbohydrate; 20% Fat; 15% Protein
OTHERFat-rich (HF)
35% Carbohydrate; 50% Fat; 15% Protein
Sponsors
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Heidelberg University
Max-Planck Institute of Molecular Cell Biology and Genetics
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed