- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005064
Middle Age muScle Krill Study (MASK)
April 27, 2026 updated by: Stuart Gray, University of Glasgow
The Effect of Krill Oil Supplementation on Muscle Function and Mass in Middle-aged Adults: A Randomised Controlled Trial
This study will determine the effect of 6 months of supplementation with krill oil on muscle strength and mass in middle-aged adults.
The study hypothesis is that krill oil supplementation will increase muscle strength and mass in middle-aged adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
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
-
-
-
Glasgow, United Kingdom
- University of Glasgow
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be 35-60 years old
- Have a BMI of less than 35kg/m2
Exclusion Criteria:
- People with diabetes, severe cardiovascular disease, seizure disorders, uncontrolled hypertension (>150/90mmHg at baseline measurement), cancer or cancer that has been in remission <5 years, ambulatory impairments which would limit the ability to perform assessments of muscle function, dementia, on anticoagulant therapy, and/or taking medication known to affect muscle (e.g., steroids).
- People who have allergies to seafood, and/or regular consumption of more than 1 portion of oily fish per week.
- People who perform regular (>1 day/week) resistance exercise training.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Krill oil 4g/day for 24 weeks
|
Superba krill oil
|
|
Placebo Comparator: Placebo
Vegetable oil 4g/day for 24 weeks
|
Mixed vegetable oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knee extensor maximal isometric torque ( MVC)
Time Frame: Change from baseline to 24 weeks
|
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
|
Change from baseline to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fat mass
Time Frame: Change from baseline to 24 weeks
|
Whole body fat mass measured by measured via bio-electrical impedance
|
Change from baseline to 24 weeks
|
|
Change in lean mass
Time Frame: Change from baseline to 24 weeks
|
Whole body lean mass measured by measured via bio-electrical impedance
|
Change from baseline to 24 weeks
|
|
Change in omega-3 levels
Time Frame: Change from baseline to 24 weeks
|
Red blood cell omega-3 levels
|
Change from baseline to 24 weeks
|
|
Change in Grip strength
Time Frame: Change from baseline to 24 weeks
|
Grip strength measured with a hand held dynamometer
|
Change from baseline to 24 weeks
|
|
Change in Muscle thickness
Time Frame: Change from baseline to 24 weeks
|
Vastus lateralis muscle thickness measured by ultrasound
|
Change from baseline to 24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in systemic inflammation
Time Frame: Change from baseline to 24 weeks
|
Plasma levels of C-reactive protein, IL-1, IL-6, IL-8, IL-10, and TNF-α
|
Change from baseline to 24 weeks
|
|
Change in muscle inflammation
Time Frame: Change from baseline to 24 weeks
|
Muscle total protein levels of TNF-α, IL-1β, IL-6, IL-8, MCP-1 and total and phosphorylated levels of NFκB, JNK1/2 and STAT3
|
Change from baseline to 24 weeks
|
|
Change in muscle anabolic signalling
Time Frame: Change from baseline to 24 weeks
|
Muscle total and phosphorylated protein levels of mTOR, IRS-1, Akt, 4EBP-1, p70S6K, RPS6, FOXO-1, GSK3β and total protein levels of MAFBx and MURF-1
|
Change from baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 1, 2023
Primary Completion (Actual)
October 1, 2025
Study Completion (Actual)
October 1, 2025
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MASK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
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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