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

NCT02487576 | Completed

• 2 other identifiers: DFG grant KFO218 PF164/16-1DDG021023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Response to Dietary Modification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Carbohydrate-rich_Fat-rich (HC_HF)

OTHER

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)

OTHER

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); Other: Fat-rich (HF)

Interventions

Carbohydrate-rich (HC) OTHER

65% Carbohydrate; 20% Fat; 15% Protein

Fat-rich_Carbohydrate-rich (HF_HC)

Fat-rich (HF) OTHER

35% Carbohydrate; 50% Fat; 15% Protein

Fat-rich_Carbohydrate-rich (HF_HC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• German Federal Ministry of Education and Research: collaborator
• Charite University, Berlin, Germany: collaborator
• Heidelberg University: collaborator
• Max-Planck Institute of Molecular Cell Biology and Genetics: collaborator

Study Sites (1)

German Institute of Human Nutrition

Potsdam, 14558, Germany

Location

Related Publications (4)

• Kessler K, Hornemann S, Petzke KJ, Kemper M, Kramer A, Pfeiffer AF, Pivovarova O, Rudovich N. The effect of diurnal distribution of carbohydrates and fat on glycaemic control in humans: a randomized controlled trial. Sci Rep. 2017 Mar 8;7:44170. doi: 10.1038/srep44170.

  PMID: 28272464 BACKGROUND

• 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.

  PMID: 30541098 BACKGROUND

• 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.

  PMID: 31680138 BACKGROUND

• Kessler K, Hornemann S, Rudovich N, Weber D, Grune T, Kramer A, Pfeiffer AFH, Pivovarova-Ramich O. Saliva Samples as A Tool to Study the Effect of Meal Timing on Metabolic And Inflammatory Biomarkers. Nutrients. 2020 Jan 28;12(2):340. doi: 10.3390/nu12020340.

  PMID: 32013045 BACKGROUND

MeSH Terms

Interventions

salmon gonadotropin

Study Officials

• Andreas FH Pfeiffer, Prof. Dr.

  German Institute of Human Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med Andreas F.H. Pfeiffer

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: July 1, 2015
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

DE (1)