Exercise Training in Healthy Young Men

August 21, 2014 updated by: Maastricht University Medical Center

The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men

Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. Whether timed protein intake could augment the increase in muscle fiber size and/or satellite cell content following long-term exercise intervention remains to be established.

We hypothesize that protein supplementation before sleep, on both training and non-training days, during a 12 week resistance training program further increases type II muscle fibre cross sectional area when compared to the placebo group.

Study Overview

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Healthy
  • Age between 18 and 30 years
  • BMI between 18.5 and 30 kg/m2
  • Recreationally active, performing sports on a non-competitive basis between 2 and 5 hours p/wk
  • Participants willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements

Exclusion Criteria:

  • HbA1C level above 6.5%
  • Fasted blood glucose level above 7 mmol/L
  • Serum creatinine level beneath 60 or above 120 µmol/L
  • Participants with a recent history or current state of COPD
  • Participants with a recent history or current state of rheumatoid arthritis
  • Participants with a recent history or current state of musculoskeletal/orthopedic disorders
  • Participants with a recent history or current state of renal disorder
  • Participants with a recent history or current state of cognitive impairment
  • Participants with orthopedic metal implants in the spine and/or upper/lower extremities
  • Participants with lactose intolerance and/or dairy protein allergy
  • Participants who are enrolled in an interventional biomedical research project or have received an investigational new drug or product with the last 30 days prior to screening.
  • Participants on medication, including anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Training + placebo drink
Exercise + non-caloric placebo drink
Experimental: Exercise + Protein drink
exercise + Drink containing Protein, Carbohydrates and Fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle fiber size
Time Frame: 12 weeks

Skeletal muscle fiber size will be assessed by muscle biopsy sampling before, during and after the 12 wks intervention period.

Muscle fiber size will be expressed in µm2

12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps cross-sectional area
Time Frame: 12 weeks

Quadriceps cross-sectional area will be assessed by CT-scan before and after the 12 wks intervention period.

Quadriceps cross-sectional area will be expressed in cm2

12 weeks
Whole body en regional body composition
Time Frame: 12 weeks

Body composition (whole-body as well as regional) well be determined by DXA-scan performed before and after the 12 wks intervention period.

Results will be expressed in kilograms

12 weeks
1RM strength
Time Frame: 12 weeks
Maximum muscle strength will be assessed before, during and after 12 wks of exercise training by means of a 1 rep max test and will be expressed in kilograms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • MEC 11-03-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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