ClinicalTrials.gg
CompletedNCT03361566EFUpdated Sep 14, 2018

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

An interventional study of physical activity and energy intake in Healthy, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.

Sponsored by University of Hohenheim · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 222 studies in Motor Activity with a site in Germany — 40 open to participants now, 48 under way, 1 of them phase 3. Motor Activity · Germany.

Enrollment
181st of 192
16 · median 88
Started
2016
with 19 others
No phase
139 of 222
33 open now
Registered
116th of 222
by date

Among the 222 studies in Motor Activity with a site in Germany, this one is the 181st largest by enrollment of the 192 interventional ones that give a count, is one of 20 that started in 2016, is one of 139 with no phase, and was the 116th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

40 of the 222 studies in Motor Activity with a site in Germany are open now. Recruiting first, the newest first:

35 more — sign in →

All 40 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 20 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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 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.

03

Conditions studied

  • Healthy

Browse trials for

Keywords

  • physical activity
  • energy balance
  • caloric restriction
  • overfeeding
  • appetite regulation
04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20-40 years of age
  • healthy
  • between 18.5 and 31 kg/m2

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    low energy flux at ad libitum energy intake

    physical activity: inactive energy intake: ad libitum

    Behavioral: physical activity · Behavioral: 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

    Behavioral: physical activity · Behavioral: 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

    Behavioral: physical activity · Behavioral: energy intake

  • Experimental
    Low energy flux at energy balance

    physical activity: inactive energy intake: individual energy balance

    Behavioral: physical activity · Behavioral: 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

    Behavioral: physical activity · Behavioral: 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

    Behavioral: physical activity · Behavioral: energy intake

  • Experimental
    low energy flux at caloric restriction

    physical activity: inactive energy intake: caloric restriction -25%

    Behavioral: physical activity · Behavioral: 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%

    Behavioral: physical activity · Behavioral: 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%

    Behavioral: physical activity · Behavioral: energy intake

  • Experimental
    low energy flux at overfeeding

    physical activity: inactive energy intake: overfeeding +25%

    Behavioral: physical activity · Behavioral: 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%

    Behavioral: physical activity · Behavioral: 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%

    Behavioral: physical activity · Behavioral: energy intake

Interventions

  • Behavioralphysical activity

    3 different levels of physical activity

  • Behavioralenergy intake

    4 different types of energy intake

06

What researchers measure

Primary outcomes

  1. energy balance

    difference between predefined energy balance and measured energy balance

    Time frame: 24 hours

Secondary outcomes

  1. ghrelin levels

    area under the curve of total plasma ghrelin

    Time frame: every 2 hours during the day over 14 hours

  2. arterial stiffness

    pulse wave velocity

    Time frame: 15 hours

07

Study locations

1 site
  • Institute of Nutritional Medicine, University of Hohenheim
    Stuttgart, 70599, Germany
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Feb 2018, 14 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 14 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Dec 5, 2017
StartActual
Dec 1, 2016
Primary completionActual
Feb 2018
CompletionActual
Mar 2018
Last update
Sep 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361566
Lead sponsor
University of Hohenheim
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Dec 1, 2016
Primary completion
Feb 2018
Completion
Mar 2018
Last update
Sep 14, 2018

Study contacts

Anja Bosy-Westphal, Prof PhD MD
principal investigator · University of Hohenheim, Stuttgart, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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