Clinical trial NCT02487576: The CLOCK Study - A Human Dietary Intervention Study on Peripheral Circadian Clocks and Energy Metabolism
Official title: Interplay of Peripheral Circadian Clocks With Energy Balance and Body Weight Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Response to Dietary Modification
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Charite University, Berlin, Germany
name: Heidelberg University
name: Max-Planck Institute of Molecular Cell Biology and Genetics
First posted: 2015-07-01
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dietary-induced changes of glucose and lipid metabolism
timeFrame: week 4
measure: Effect of different diurnal patterns of meal composition on peripheral circadian clocks in blood cells and subcutaneous adipose tissue
timeFrame: week 4
Secondary outcomes:
measure: Dietary-induced changes of satiety and hunger scores
timeFrame: week 4
measure: Effect of different diurnal patterns of meal composition on Lipopolysaccharide-induced cytokine expression
timeFrame: week 4
measure: Dietary-induced changes of the human adipose tissue lipidome
timeFrame: week 4
measure: Integrative analysis of dietary-induced changes of the human adipose tissue transcriptome
timeFrame: week 4
Other outcomes:
Locations:
city: Potsdam-Rehbruecke
country: Germany
facility: German Institute of Human Nutrition
state: Nuthetal
Study officials:
affiliation: German Institute of Human Nutrition
name: Andreas FH Pfeiffer, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Kessler K, Gerl MJ, Hornemann S, Damm M, Klose C, Petzke KJ, Kemper M, Weber D, Rudovich N, Grune T, Simons K, Kramer A, Pfeiffer AFH, Pivovarova-Ramich O. Shotgun Lipidomics Discovered Diurnal Regulation of Lipid Metabolism Linked to Insulin Sensitivity in Nondiabetic Men. J Clin Endocrinol Metab. 2020 May 1;105(5):dgz176. doi: 10.1210/clinem/dgz176.
citation: Kessler K, Hornemann S, Petzke KJ, Kemper M, Markova M, Rudovich N, Grune T, Kramer A, Pfeiffer AFH, Pivovarova-Ramich O. Diurnal distribution of carbohydrates and fat affects substrate oxidation and adipokine secretion in humans. Am J Clin Nutr. 2018 Dec 1;108(6):1209-1219. doi: 10.1093/ajcn/nqy224.