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Completed

NCT Number: NCT03361566

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

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.

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Key information

Conditions

Healthy Behavior Motor Activity

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

3 different levels of physical activity

energy intake

Behavioral

4 different types of energy intake

Primary outcomes

  1. energy balance

    Time frame: 24 hours

    difference between predefined energy balance and measured energy balance

Secondary outcomes

  1. ghrelin levels

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

    area under the curve of total plasma ghrelin

  2. arterial stiffness

    Time frame: 15 hours

    pulse wave velocity

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz

Acronym: EF

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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