Preservation of Fat Free Mass During Weight Loss

Muscle Loss Clinical Trial

Official title:

Preservation of Fat Free Mass During Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102372
• Other study ID #: Section of Sport Science, AU
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: April 5, 2017
• Start date: January 8, 2016
• Est. completion date: May 2, 2016

Study information

• Verified date: February 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we aimed to examine the effect of whey protein supplementation given before night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet (VLCD).

Half of the participants underwent a 4 week VLCD and walking program, while the other half underwent a 4 week VLCD, walking program and had an additional protein supplement before each night sleep.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2, 2016
• Est. primary completion date: April 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (kg/m^2) > 28

• Age between 18 and 55 years

Exclusion Criteria:

• Participation in regular resistance-, aerobic- or anaerobic training (>1 h/wk within the last 3 month before intervention start)

• Diabetes Physical disabilities that would hinder completion of the walking program.

Related Conditions & MeSH terms

• Muscle Loss
• Weight Loss

Intervention

Dietary Supplement:
• Whey protein supplementation

Other:
• walking program

• Very Low Calorie Diet

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Orkla Health, Tømmerhandler Vilhelm Bangs Fond, Toyota-Fonden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Free Mass	Dual energy X-ray absorptiometry (DXA)	Change from baseline to after the 4 week intervention period
Secondary	Nitrogen balance	Three 24 hours urin samples	Change in nitrogen content from baseline to day 7 and 28 of the intervention period
Secondary	Oral glucose tolerance test	OGTT	Change from baseline to after the 4 week intervention period
Secondary	Fitness level	Bike test	Change from baseline to after the 4 week intervention period
Secondary	Blood pressure	Blood pressure at rest	Change from baseline to after the 4 week intervention period
Secondary	Fat mass	DXA	Change from baseline to after the 4 week intervention period
Secondary	waist circumference	waist circumference	Change from baseline to after the 4 week intervention period
Secondary	Performance test	Intermittent running test (YY1R1C)	Change from baseline to after the 4 week intervention period