HealthyEFNCT03361566
Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux
A study testing physical activity and energy intake in people with Healthy, run by University of Hohenheim at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- physical activity and energy intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 years of age
- healthy
- BMI between 18.5 and 31 kg/m2
Who cannot join
- smoking
- food allergies
- alternative nutrition habits like vegetarian / vegan
- chronic diseases
- regular medication intake
- claustrophobia
- weight loss > 5 kg in the last 3 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- physical activity, energy intake
- Keywords
- physical activity, energy balance, caloric restriction, overfeeding, appetite regulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
3 different levels of physical activity
energy intakeBehavioural
4 different types of energy intake
| Study group | Role | What they receive |
|---|---|---|
| low energy flux at ad libitum energy intake | Experimental | physical activity: inactive energy intake: ad libitum Receives: Behavioral: physical activity; Behavioral: energy intake |
| medium energy flux at ad libitum energy intake | Experimental | physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum Receives: Behavioral: physical activity; Behavioral: energy intake |
| high energy flux at ad libitum energy intake | Experimental | physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum Receives: Behavioral: physical activity; Behavioral: energy intake |
| Low energy flux at energy balance | Experimental | physical activity: inactive energy intake: individual energy balance Receives: Behavioral: physical activity; Behavioral: energy intake |
| medium energy flux at energy balance | Experimental | physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance Receives: Behavioral: physical activity; Behavioral: energy intake |
| high energy flux at energy balance | Experimental | physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance Receives: Behavioral: physical activity; Behavioral: energy intake |
| low energy flux at caloric restriction | Experimental | physical activity: inactive energy intake: caloric restriction -25% Receives: Behavioral: physical activity; Behavioral: energy intake |
| medium energy flux at caloric restriction | Experimental | physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25% Receives: Behavioral: physical activity; Behavioral: energy intake |
| high energy flux at caloric restriction | Experimental | physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25% Receives: Behavioral: physical activity; Behavioral: energy intake |
| low energy flux at overfeeding | Experimental | physical activity: inactive energy intake: overfeeding +25% Receives: Behavioral: physical activity; Behavioral: energy intake |
| medium energy flux at overfeeding | Experimental | physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25% Receives: Behavioral: physical activity; Behavioral: energy intake |
| high energy flux at overfeeding | Experimental | physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25% Receives: Behavioral: physical activity; Behavioral: energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy balance
difference between predefined energy balance and measured energy balance
Measured: 24 hours
Secondary outcomes (2)
ghrelin levels
area under the curve of total plasma ghrelin
Measured: every 2 hours during the day over 14 hours
arterial stiffness
pulse wave velocity
Measured: 15 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Dec 2016
- Primary completionFeb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Bosy-Westphal, Prof PhD MD, Principal investigator, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361566
- Sponsor's protocol ID
- EF2016
- Acronym
- EF
- Status last verified
- Sep 2018
- First submitted
- 9 Oct 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagele FA, Busing F, Nas A, Hasler M, Muller MJ, Blundell JE, Bosy-Westphal A. Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4481-4491. doi: 10.1210/jc.2019-01164.
PubMed 31305927
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz
- ClinicalTrials.gov ID
- NCT03361566
- Acronym / sponsor ID
- EF / EF2016
- Conditions
- Healthy
- Keywords
- physical activity, energy balance, caloric restriction, overfeeding, appetite regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| low energy flux at ad libitum energy intake | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: inactive energy intake: ad libitum |
| medium energy flux at ad libitum energy intake | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum |
| high energy flux at ad libitum energy intake | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum |
| Low energy flux at energy balance | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: inactive energy intake: individual energy balance |
| medium energy flux at energy balance | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance |
| high energy flux at energy balance | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance |
| low energy flux at caloric restriction | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: inactive energy intake: caloric restriction -25% |
| medium energy flux at caloric restriction | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25% |
| high energy flux at caloric restriction | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25% |
| low energy flux at overfeeding | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: inactive energy intake: overfeeding +25% |
| medium energy flux at overfeeding | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25% |
| high energy flux at overfeeding | Experimental | Behavioral: physical activity, Behavioral: energy intakephysical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25% |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-40 years of age
- healthy
- BMI between 18.5 and 31 kg/m2
Key exclusion criteria (7 listed)
- smoking
- food allergies
- alternative nutrition habits like vegetarian / vegan
- chronic diseases
- regular medication intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity3 different levels of physical activity | Behavioural | Low energy flux at energy balance, high energy flux at ad libitum energy intake, high energy flux at caloric restriction, high energy flux at energy balance, high energy flux at overfeeding, low energy flux at ad libitum energy intake, low energy flux at caloric restriction, low energy flux at overfeeding, medium energy flux at ad libitum energy intake, medium energy flux at caloric restriction, medium energy flux at energy balance, medium energy flux at overfeeding |
| energy intake4 different types of energy intake | Behavioural | Low energy flux at energy balance, high energy flux at ad libitum energy intake, high energy flux at caloric restriction, high energy flux at energy balance, high energy flux at overfeeding, low energy flux at ad libitum energy intake, low energy flux at caloric restriction, low energy flux at overfeeding, medium energy flux at ad libitum energy intake, medium energy flux at caloric restriction, medium energy flux at energy balance, medium energy flux at overfeeding |
Primary outcome
energy balance
Time frame: 24 hours
difference between predefined energy balance and measured energy balance
2 secondary outcomes
ghrelin levels
Time frame: every 2 hours during the day over 14 hours
arterial stiffness
Time frame: 15 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Derived from this study: PubMed 31305927Hagele FA, Busing F, Nas A, Hasler M, Muller MJ, Blundell JE, Bosy-Westphal A. Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4481-4491. doi: 10.1210/jc.2019-01164.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Bosy-Westphal, Prof PhD MD principal investigator
University of Hohenheim, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity and energy intake in people with Healthy, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy balance (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.