NCT03361566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

October 9, 2017

Last Update Submit

September 13, 2018

Conditions

Healthy

Keywords

physical activityenergy balancecaloric restrictionoverfeedingappetite regulation

Outcome Measures

Primary Outcomes (1)

  • energy balance

    difference between predefined energy balance and measured energy balance

    24 hours

Secondary Outcomes (2)

  • ghrelin levels

    every 2 hours during the day over 14 hours

  • arterial stiffness

    15 hours

Study Arms (12)

low energy flux at ad libitum energy intake

EXPERIMENTAL

physical activity: inactive energy intake: ad libitum

Behavioral: physical activityBehavioral: 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

Behavioral: physical activityBehavioral: 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

Behavioral: physical activityBehavioral: energy intake

Low energy flux at energy balance

EXPERIMENTAL

physical activity: inactive energy intake: individual energy balance

Behavioral: physical activityBehavioral: 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

Behavioral: physical activityBehavioral: 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

Behavioral: physical activityBehavioral: energy intake

low energy flux at caloric restriction

EXPERIMENTAL

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

Behavioral: physical activityBehavioral: 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%

Behavioral: physical activityBehavioral: 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%

Behavioral: physical activityBehavioral: energy intake

low energy flux at overfeeding

EXPERIMENTAL

physical activity: inactive energy intake: overfeeding +25%

Behavioral: physical activityBehavioral: 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%

Behavioral: physical activityBehavioral: 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%

Behavioral: physical activityBehavioral: energy intake

Interventions

physical activityBEHAVIORAL

3 different levels of physical activity

Low energy flux at energy balancehigh energy flux at ad libitum energy intakehigh energy flux at caloric restrictionhigh energy flux at energy balancehigh energy flux at overfeedinglow energy flux at ad libitum energy intakelow energy flux at caloric restrictionlow energy flux at overfeedingmedium energy flux at ad libitum energy intakemedium energy flux at caloric restrictionmedium energy flux at energy balancemedium energy flux at overfeeding
energy intakeBEHAVIORAL

4 different types of energy intake

Low energy flux at energy balancehigh energy flux at ad libitum energy intakehigh energy flux at caloric restrictionhigh energy flux at energy balancehigh energy flux at overfeedinglow energy flux at ad libitum energy intakelow energy flux at caloric restrictionlow energy flux at overfeedingmedium energy flux at ad libitum energy intakemedium energy flux at caloric restrictionmedium energy flux at energy balancemedium energy flux at overfeeding

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • healthy
  • BMI between 18.5 and 31 kg/m2

You may not qualify if:

  • smoking
  • food allergies
  • alternative nutrition habits like vegetarian / vegan
  • chronic diseases
  • regular medication intake
  • claustrophobia
  • weight loss \> 5 kg in the last 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31305927DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseEnergy Intake

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Anja Bosy-Westphal, Prof PhD MD

    University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

December 5, 2017

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)