Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux (EF)
September 13, 2018 updated by: University of Hohenheim
Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stuttgart, Germany, 70599
- Institute of Nutritional Medicine, University of Hohenheim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low energy flux at ad libitum energy intake
physical activity: inactive energy intake: ad libitum
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: medium energy flux at ad libitum energy intake
physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: high energy flux at ad libitum energy intake
physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: Low energy flux at energy balance
physical activity: inactive energy intake: individual energy balance
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: medium energy flux at energy balance
physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: high energy flux at energy balance
physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: low energy flux at caloric restriction
physical activity: inactive energy intake: caloric restriction -25%
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: medium energy flux at caloric restriction
physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: high energy flux at caloric restriction
physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: low energy flux at overfeeding
physical activity: inactive energy intake: overfeeding +25%
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: medium energy flux at overfeeding
physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25%
|
3 different levels of physical activity
4 different types of energy intake
|
|
Experimental: high energy flux at overfeeding
physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25%
|
3 different levels of physical activity
4 different types of energy intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
energy balance
Time Frame: 24 hours
|
difference between predefined energy balance and measured energy balance
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ghrelin levels
Time Frame: every 2 hours during the day over 14 hours
|
area under the curve of total plasma ghrelin
|
every 2 hours during the day over 14 hours
|
|
arterial stiffness
Time Frame: 15 hours
|
pulse wave velocity
|
15 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anja Bosy-Westphal, Prof PhD MD, University of Hohenheim, Stuttgart, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 9, 2017
First Submitted That Met QC Criteria
November 28, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
September 14, 2018
Last Update Submitted That Met QC Criteria
September 13, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- EF2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.