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

Healthy Clinical Trial

— EF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361566
• Other study ID #: EF2016
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• physical activity
3 different levels of physical activity
• energy intake
4 different types of energy intake

Locations

Country	Name	City	State
Germany	Institute of Nutritional Medicine, University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy balance	difference between predefined energy balance and measured energy balance	24 hours
Secondary	ghrelin levels	area under the curve of total plasma ghrelin	every 2 hours during the day over 14 hours
Secondary	arterial stiffness	pulse wave velocity	15 hours