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

Skeletal Muscle Mass Regulation Clinical Trial

— NSAID2015  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531451
• Other study ID #: 2014-004872-47
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2015
• Last updated: June 27, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Skeletal Muscle Mass Regulation

Intervention

Drug:
• Ibuprofen

• Acetylsalicylic acid

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quadriceps muscle volume	Measured through MRI	Baseline and after 8 weeks training	No
Secondary	Change in muscle gene expression	Through quantitative PCR and microarray	Baseline, 4 weeks and after 8 weeks training	No
Secondary	Change in muscle protein expression	Through Western Blots	Baseline, 4 weeks and after 8 weeks training	No
Secondary	Change in Quadriceps muscle strength	Measured in strength dynamometers	Baseline and after 8 weeks training	No