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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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

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Metabolic Response to Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

No interventions assigned to this group

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

Group Type OTHER

Carbohydrate-rich (HC)

Intervention Type OTHER

65% Carbohydrate; 20% Fat; 15% Protein

Fat-rich (HF)

Intervention Type OTHER

35% Carbohydrate; 50% Fat; 15% Protein

Interventions

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Carbohydrate-rich (HC)

65% Carbohydrate; 20% Fat; 15% Protein

Intervention Type OTHER

Fat-rich (HF)

35% Carbohydrate; 50% Fat; 15% Protein

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes