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

German Institute of Human Nutrition32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Metabolic Response to Dietary Modification

Interventions

Carbohydrate-rich (HC)OTHER

65% Carbohydrate; 20% Fat; 15% Protein

Fat-rich (HF)OTHER

35% Carbohydrate; 50% Fat; 15% Protein

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

German Institute of Human Nutrition

Potsdam, Germany

Outcomes

Primary Outcomes

Dietary-induced changes of glucose and lipid metabolism

Time frame: week 4

Effect of different diurnal patterns of meal composition on peripheral circadian clocks in blood cells and subcutaneous adipose tissue

Time frame: week 4

Secondary Outcomes

Dietary-induced changes of satiety and hunger scores

Measured via visual analogue scales

Time frame: week 4

Effect of different diurnal patterns of meal composition on Lipopolysaccharide-induced cytokine expression

Time frame: week 4

Dietary-induced changes of the human adipose tissue lipidome

Time frame: week 4

Integrative analysis of dietary-induced changes of the human adipose tissue transcriptome

Microarray Analysis of adipose tissue samples

Time frame: week 4

Data from ClinicalTrials.gov

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