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

NCT ID: NCT03361566

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-03-31

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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low energy flux at ad libitum energy intake

physical activity: inactive energy intake: ad libitum

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

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

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

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

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

Low energy flux at energy balance

physical activity: inactive energy intake: individual energy balance

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

medium energy flux at energy balance

physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

high energy flux at energy balance

physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

low energy flux at caloric restriction

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

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

medium energy flux at caloric restriction

physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25%

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

high energy flux at caloric restriction

physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25%

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

low energy flux at overfeeding

physical activity: inactive energy intake: overfeeding +25%

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

medium energy flux at overfeeding

physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25%

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

high energy flux at overfeeding

physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25%

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

3 different levels of physical activity

energy intake

Intervention Type BEHAVIORAL

4 different types of energy intake

Interventions

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physical activity

3 different levels of physical activity

Intervention Type BEHAVIORAL

energy intake

4 different types of energy intake

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anja Bosy-Westphal, Prof PhD MD

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim, Stuttgart, Germany

Locations

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Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 31305927 (View on PubMed)

Other Identifiers

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EF2016

Identifier Type: -

Identifier Source: org_study_id

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