NCT01325038

Brief Summary

Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins. Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured by registration of CO2 production and O2 consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

March 28, 2011

Last Update Submit

March 28, 2011

Conditions

Healthy Subjects

Keywords

resting metabolic rate

Outcome Measures

Primary Outcomes (1)

  • change in resting metabolic rate

    measurement of resting metabolic rate at baseline and at the end of the three month trial period

    3 months

Secondary Outcomes (1)

  • change in muscle mass

    3 months

Study Arms (2)

extra protein supplement

ACTIVE COMPARATOR

isometric training with addition of extra protein

Procedure: Isometric exercise

extra food supplement

ACTIVE COMPARATOR

isometric exercise with addition of extra food and calories: one fast food meal/day

Procedure: Isometric exercise

Interventions

Isometric exercisePROCEDURE

Isometric exercise several times/week for three months

extra food supplementextra protein supplement

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males

You may not qualify if:

  • significant disease
  • inability to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Linkoping

Linköping, Sweden, 58185, Sweden

Location

Related Publications (1)

  • Hambre D, Vergara M, Lood Y, Bachrach-Lindstrom M, Lindstrom T, Nystrom FH. A randomized trial of protein supplementation compared with extra fast food on the effects of resistance training to increase metabolism. Scand J Clin Lab Invest. 2012 Oct;72(6):471-8. doi: 10.3109/00365513.2012.698021. Epub 2012 Aug 30.

    PMID: 22935042DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

August 1, 2009

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

SE(1)