NCT02487576

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

Interplay of Peripheral Circadian Clocks With Energy Balance and Body Weight Regulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: German Institute of Human Nutrition · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Response to Dietary Modification

Interventions

Type	Name	Description
OTHER	Carbohydrate-rich (HC)	65% Carbohydrate; 20% Fat; 15% Protein
OTHER	Fat-rich (HF)	35% Carbohydrate; 50% Fat; 15% Protein

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-07-01
• Last updated: 2025-08-26

Locations

1 site across 1 country: Germany