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The CLOCK Study - A Human Dietary Intervention Study on Peripheral Circadian Clocks and Energy Metabolism (CLOCK)

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ClinicalTrials.gov Identifier: NCT02487576
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Heidelberg University
Max-Planck Institute of Molecular Cell Biology and Genetics
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Response to Dietary Modification Other: Carbohydrate-rich (HC) Other: Fat-rich (HF) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Interplay of Peripheral Circadian Clocks With Energy Balance and Body Weight Regulation
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
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
 Other: Carbohydrate-rich (HC)
65% Carbohydrate; 20% Fat; 15% Protein

Other: Fat-rich (HF)
35% Carbohydrate; 50% Fat; 15% Protein
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
 Other: Carbohydrate-rich (HC)
65% Carbohydrate; 20% Fat; 15% Protein

Other: Fat-rich (HF)
35% Carbohydrate; 50% Fat; 15% Protein


Outcome Measures
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Primary Outcome Measures :
  1. Dietary-induced changes of glucose and lipid metabolism [ Time Frame: week 4 ]
  2. Effect of different diurnal patterns of meal composition on peripheral circadian clocks in blood cells and subcutaneous adipose tissue [ Time Frame: week 4 ]

Secondary Outcome Measures :
  1. Dietary-induced changes of satiety and hunger scores [ Time Frame: week 4 ]
    Measured via visual analogue scales

  2. Effect of different diurnal patterns of meal composition on Lipopolysaccharide-induced cytokine expression [ Time Frame: week 4 ]
  3. Dietary-induced changes of the human adipose tissue lipidome [ Time Frame: week 4 ]
  4. Integrative analysis of dietary-induced changes of the human adipose tissue transcriptome [ Time Frame: week 4 ]
    Microarray Analysis of adipose tissue samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487576


Locations
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Germany
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany, 14558
Sponsors and Collaborators
German Institute of Human Nutrition
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Heidelberg University
Max-Planck Institute of Molecular Cell Biology and Genetics
Investigators
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Study Director: Andreas FH Pfeiffer, Prof. Dr. German Institute of Human Nutrition
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Prof. Dr. med Andreas F.H. Pfeiffer, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02487576    
Other Study ID Numbers: DFG grant KFO218 PF164/16-1
DDG021023 ( Other Grant/Funding Number: Deutsche Diabetes Gesellschaft )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015