MASK: Middle Age muScle Krill Study

Sponsor
University of Glasgow (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06005064
Collaborator
(none)
92
1
2
12
7.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Krill oil
  • Dietary Supplement: Vegetable oil
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 basis1:1 basis
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Supplements will be identical in look and taste
Primary Purpose:
Prevention
Official Title:
The Effect of Krill Oil Supplementation on Muscle Function and Mass in Middle-aged Adults: A Randomised Controlled Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Krill oil 4g/day for 24 weeks

Dietary Supplement: Krill oil
Superba krill oil

Placebo Comparator: Placebo

Vegetable oil 4g/day for 24 weeks

Dietary Supplement: Vegetable oil
Mixed vegetable oil

Outcome Measures

Primary Outcome Measures

  1. Change in knee extensor maximal isometric torque ( MVC) [Change from baseline to 24 weeks]

    Knee extensor maximal isometric torque measured during a maximal voluntary contraction

Secondary Outcome Measures

  1. Change in fat mass [Change from baseline to 24 weeks]

    Whole body fat mass measured by measured via bio-electrical impedance

  2. Change in lean mass [Change from baseline to 24 weeks]

    Whole body lean mass measured by measured via bio-electrical impedance

  3. Change in omega-3 levels [Change from baseline to 24 weeks]

    Red blood cell omega-3 levels

  4. Change in Grip strength [Change from baseline to 24 weeks]

    Grip strength measured with a hand held dynamometer

  5. Change in Muscle thickness [Change from baseline to 24 weeks]

    Vastus lateralis muscle thickness measured by ultrasound

Other Outcome Measures

  1. Change in systemic inflammation [Change from baseline to 24 weeks]

    Plasma levels of C-reactive protein, IL-1, IL-6, IL-8, IL-10, and TNF-α

  2. Change in muscle inflammation [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

  3. Change in muscle anabolic signalling [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Glasgow Glasgow United Kingdom

Sponsors and Collaborators

  • University of Glasgow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stuart Gray, Professor, University of Glasgow
ClinicalTrials.gov Identifier:
NCT06005064
Other Study ID Numbers:
  • MASK
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stuart Gray, Professor, University of Glasgow
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023