Back to resultsPreservation of Fat Free Mass During Weight Loss
Primary Purpose
Muscle Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whey protein supplementation
walking program
Very Low Calorie Diet
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Loss focused on measuring FFM, VLCD, exercise, Protein, Obesity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Protein group
Placebo group
Arm Description
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Outcomes
Primary Outcome Measures
Fat Free Mass
Dual energy X-ray absorptiometry (DXA)
Secondary Outcome Measures
Nitrogen balance
Three 24 hours urin samples
Oral glucose tolerance test
OGTT
Fitness level
Bike test
Blood pressure
Blood pressure at rest
Fat mass
DXA
waist circumference
waist circumference
Performance test
Intermittent running test (YY1R1C)
Full Information
NCT ID
NCT03102372
First Posted
March 10, 2017
Last Updated
April 5, 2017
Sponsor
University of Aarhus
Collaborators
Orkla Health, Toyota-Fonden, Tømmerhandler Vilhelm Bangs Fond
1. Study Identification
Unique Protocol Identification Number
NCT03102372
Brief Title
Preservation of Fat Free Mass During Weight Loss
Official Title
Preservation of Fat Free Mass During Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2016 (Actual)
Primary Completion Date
April 4, 2016 (Actual)
Study Completion Date
May 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Orkla Health, Toyota-Fonden, Tømmerhandler Vilhelm Bangs Fond
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Loss
Keywords
FFM, VLCD, exercise, Protein, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized single blinded, controlled intervention trial
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein group
Arm Type
Experimental
Arm Description
4 weeks of a Very Low Calorie Diet (VLCD) + walking program. Whey protein supplementation 0.4g/kg before sleep.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
4 weeks of a Very Low Calorie Diet (VLCD) + walking program
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein supplementation
Intervention Type
Other
Intervention Name(s)
walking program
Intervention Type
Other
Intervention Name(s)
Very Low Calorie Diet
Primary Outcome Measure Information:
Title
Fat Free Mass
Description
Dual energy X-ray absorptiometry (DXA)
Time Frame
Change from baseline to after the 4 week intervention period
Secondary Outcome Measure Information:
Title
Nitrogen balance
Description
Three 24 hours urin samples
Time Frame
Change in nitrogen content from baseline to day 7 and 28 of the intervention period
Title
Oral glucose tolerance test
Description
OGTT
Time Frame
Change from baseline to after the 4 week intervention period
Title
Fitness level
Description
Bike test
Time Frame
Change from baseline to after the 4 week intervention period
Title
Blood pressure
Description
Blood pressure at rest
Time Frame
Change from baseline to after the 4 week intervention period
Title
Fat mass
Description
DXA
Time Frame
Change from baseline to after the 4 week intervention period
Title
waist circumference
Description
waist circumference
Time Frame
Change from baseline to after the 4 week intervention period
Title
Performance test
Description
Intermittent running test (YY1R1C)
Time Frame
Change from baseline to after the 4 week intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Hansen, Lector
Organizational Affiliation
Aarhus University, Department for Public Health, Section for Sport Science
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preservation of Fat Free Mass During Weight Loss
We'll reach out to this number within 24 hrs