Energy Expenditure, Sleep and Macronutrients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

Detailed Description
-----------------
The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.

Official Title
-----------------
Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio

Conditions
-----------------
Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Signs and Symptoms

Intervention / Treatment
-----------------
* Dietary Supplement: Differences in protein content of meals
* Dietary Supplement: Differences in protein content of meals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy age between 18-35 years BMI 18-27 kg/m2 non-smoking weight stable (weight change < 3 kg during the last 6 months) no sleeping problems not using a more than moderate amount of alcohol (> 10 consumptions/wk) not using medication or supplements except for oral contraceptives in women Exclusion Criteria: not healthy do not meet the criteria for BMI and age smoking not being weight stable using medication or supplements except for oral contraceptives in women sleeping problems using a more than moderate alcohol consumption pregnant or lactating allergic for the used food items

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein intake of 5 energy percent<br> | Dietary Supplement: Differences in protein content of meals<br>* Differences in protein content (energy percent) of meals<br>|
| Experimental: Protein intake of 30 energy percent<br> | Dietary Supplement: Differences in protein content of meals<br>* Differences in protein content (energy percent) of meals<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy expenditure |  | 48 hours | 
| substrate oxidation |  | 48 hours | 
| sleep |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | 48 hours | 
| fat distribution |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy expenditure, Sleep, Protein, Carbohydrate