The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults (NSAID2015)

June 27, 2016 updated by: Tommy Lundberg, Karolinska Institutet

The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise

In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

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

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska Institutet

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Considered healthy
  • Moderately trained
  • 18-35 yrs

Exclusion Criteria:

  • Cardiovascular disease
  • Impaired kidney or liver function
  • Lower limb injury
  • Pregnancy
  • Ulcer or gastrointestinal upsets
  • Previous reactions to use of NSAID

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen
Resistance exercise 20 sessions during 8 weeks Daily consumption of 1200 mg ibuprofen (400 mg x 3) during 8 weeks
Drug: Ibuprofen
Active Comparator: Acetylsalicylic acid
Resistance exercise 20 sessions during 8 weeks Daily consumption of 75 mg acetylsalicylic acid (75 mg x 1) during 8 weeks
Drug: Acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quadriceps muscle volume
Time Frame: Baseline and after 8 weeks training
Measured through MRI
Baseline and after 8 weeks training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle gene expression
Time Frame: Baseline, 4 weeks and after 8 weeks training
Through quantitative PCR and microarray
Baseline, 4 weeks and after 8 weeks training
Change in muscle protein expression
Time Frame: Baseline, 4 weeks and after 8 weeks training
Through Western Blots
Baseline, 4 weeks and after 8 weeks training
Change in Quadriceps muscle strength
Time Frame: Baseline and after 8 weeks training
Measured in strength dynamometers
Baseline and after 8 weeks training

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Tommy Lundberg, PhD, Karolinska Institutet

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

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-004872-47

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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