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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: physical activity; Behavioral: energy intake

• Registration Number: NCT03361566
• Lead Sponsor: University of Hohenheim

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.

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-05
• Primary Completion: 2018-02
• Study Completion: 2018-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low energy flux at ad libitum energy intake	physical activity	physical activity: inactive energy intake: ad libitum
low energy flux at caloric restriction	physical activity	physical activity: inactive energy intake: caloric restriction -25%
medium energy flux at caloric restriction	physical activity	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
medium energy flux at energy balance	energy intake	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance
medium energy flux at energy balance	physical activity	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: individual energy balance
high energy flux at energy balance	energy intake	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance
medium energy flux at ad libitum energy intake	energy intake	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum
Low energy flux at energy balance	energy intake	physical activity: inactive energy intake: individual energy balance
high energy flux at energy balance	physical activity	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: individual energy balance
medium energy flux at caloric restriction	energy intake	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
high energy flux at caloric restriction	energy intake	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
low energy flux at overfeeding	energy intake	physical activity: inactive energy intake: overfeeding +25%
high energy flux at ad libitum energy intake	energy intake	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum
medium energy flux at overfeeding	physical activity	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25%
medium energy flux at overfeeding	energy intake	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: overfeeding +25%
low energy flux at ad libitum energy intake	energy intake	physical activity: inactive energy intake: ad libitum
medium energy flux at ad libitum energy intake	physical activity	physical activity: medium (3 x 55 min treadmill running at 4 km/h) energy intake: ad libitum
high energy flux at ad libitum energy intake	physical activity	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: ad libitum
Low energy flux at energy balance	physical activity	physical activity: inactive energy intake: individual energy balance
low energy flux at caloric restriction	energy intake	physical activity: inactive energy intake: caloric restriction -25%
high energy flux at caloric restriction	physical activity	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: caloric restriction -25%
high energy flux at overfeeding	physical activity	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25%
low energy flux at overfeeding	physical activity	physical activity: inactive energy intake: overfeeding +25%
high energy flux at overfeeding	energy intake	physical activity: high (3 x 110 min treadmill running at 4 km/h) energy intake: overfeeding +25%

Primary Outcome Measures

Name	Time	Method
energy balance	24 hours	difference between predefined energy balance and measured energy balance

Secondary Outcome Measures

Name	Time	Method
ghrelin levels	every 2 hours during the day over 14 hours	area under the curve of total plasma ghrelin
arterial stiffness	15 hours	pulse wave velocity

Trial Locations

Locations (1)

Institute of Nutritional Medicine, University of Hohenheim; 🇩🇪 Stuttgart, Germany