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Middle Age muScle Krill Study (MASK)

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Krill oil
Vegetable oil
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Krill oil, Muscle strength, Muscle mass, Middle-aged

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Glasgow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Krill oil 4g/day for 24 weeks

Vegetable oil 4g/day for 24 weeks

Outcomes

Primary Outcome Measures

Change in knee extensor maximal isometric torque ( MVC)
Knee extensor maximal isometric torque measured during a maximal voluntary contraction

Secondary Outcome Measures

Change in fat mass
Whole body fat mass measured by measured via bio-electrical impedance
Change in lean mass
Whole body lean mass measured by measured via bio-electrical impedance
Change in omega-3 levels
Red blood cell omega-3 levels
Change in Grip strength
Grip strength measured with a hand held dynamometer
Change in Muscle thickness
Vastus lateralis muscle thickness measured by ultrasound

Full Information

First Posted
August 16, 2023
Last Updated
August 16, 2023
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT06005064
Brief Title
Middle Age muScle Krill Study
Acronym
MASK
Official Title
The Effect of Krill Oil Supplementation on Muscle Function and Mass in Middle-aged Adults: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Krill oil, Muscle strength, Muscle mass, Middle-aged

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 basis
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Supplements will be identical in look and taste
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Krill oil 4g/day for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vegetable oil 4g/day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill oil
Intervention Description
Superba krill oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable oil
Intervention Description
Mixed vegetable oil
Primary Outcome Measure Information:
Title
Change in knee extensor maximal isometric torque ( MVC)
Description
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Time Frame
Change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change in fat mass
Description
Whole body fat mass measured by measured via bio-electrical impedance
Time Frame
Change from baseline to 24 weeks
Title
Change in lean mass
Description
Whole body lean mass measured by measured via bio-electrical impedance
Time Frame
Change from baseline to 24 weeks
Title
Change in omega-3 levels
Description
Red blood cell omega-3 levels
Time Frame
Change from baseline to 24 weeks
Title
Change in Grip strength
Description
Grip strength measured with a hand held dynamometer
Time Frame
Change from baseline to 24 weeks
Title
Change in Muscle thickness
Description
Vastus lateralis muscle thickness measured by ultrasound
Time Frame
Change from baseline to 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in systemic inflammation
Description
Plasma levels of C-reactive protein, IL-1, IL-6, IL-8, IL-10, and TNF-α
Time Frame
Change from baseline to 24 weeks
Title
Change in muscle inflammation
Description
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
Time Frame
Change from baseline to 24 weeks
Title
Change in muscle anabolic signalling
Description
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
Time Frame
Change from baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Gray, PhD
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Stuart Gray, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Middle Age muScle Krill Study

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