Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux

Study Overview
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Brief Summary
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Aim of the study is to investigate the impact of energy flux (achieved by changes in physical activity) under the conditions of energy balance, caloric restriction and overfeeding in healthy subjects.

Detailed Description
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A low energy flux is achieved by low energy expenditure, equivalent to low physical activity and with a corresponding low energy intake. A high energy flux is achieved by high energy expenditure, equivalent to high physical activity and with a corresponding high energy intake, respectively. The protocol of this randomized, intra-individual nutrition intervention includes 12 one-day interventions with 3 different levels of energy flux and 4 different diet conditions.

Official Title
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Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: physical activity
* Behavioral: energy intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-40 years of age healthy BMI between 18.5 and 31 kg/m2 Exclusion Criteria: smoking food allergies alternative nutrition habits like vegetarian / vegan chronic diseases regular medication intake claustrophobia weight loss > 5 kg in the last 3 years

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low energy flux at ad libitum energy intake<br>physical activity: inactive energy intake: ad libitum | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: medium energy flux at ad libitum energy intake<br>physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: high energy flux at ad libitum energy intake<br>physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: Low energy flux at energy balance<br>physical activity: inactive energy intake: individual energy balance | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: medium energy flux at energy balance<br>physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: high energy flux at energy balance<br>physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: low energy flux at caloric restriction<br>physical activity: inactive energy intake: caloric restriction -25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: medium energy flux at caloric restriction<br>physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: high energy flux at caloric restriction<br>physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: low energy flux at overfeeding<br>physical activity: inactive energy intake: overfeeding +25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: medium energy flux at overfeeding<br>physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|
| Experimental: high energy flux at overfeeding<br>physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25% | Behavioral: physical activity<br>* 3 different levels of physical activity<br>Behavioral: energy intake<br>* 4 different types of energy intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy balance | difference between predefined energy balance and measured energy balance | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ghrelin levels | area under the curve of total plasma ghrelin | every 2 hours during the day over 14 hours | 
| arterial stiffness | pulse wave velocity | 15 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, energy balance, caloric restriction, overfeeding, appetite regulation