Back to resultsA Comparison of the Effects of Krill Oil and Fish Oil Supplementation on Muscle Function in Older Adults
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fish oil
Kril oil
Vegetable oil
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring muscle mass, strength, omega-3, ageing
Eligibility Criteria
Inclusion Criteria: Older adults (aged 60 years or older). BMI less than 30kg/m2 Exclusion Criteria: Participants (diagnosed and being treated for a pre-existing medical condition (cancer, kidney disease, liver disease, diabetes mellitus and cardiovascular disease, uncontrolled hypertension, gait disturbances limiting the ability to perform assessments of muscle function, dementia, affecting muscles known to use drugs (e.g., steroids). History of allergy to fish or fish oil and regular consumption of more than1portion of oily fish per week or use of fish oil or krill oil supplements will also be excluded.
Sites / Locations
- Stuart Robert GrayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Fish oil
Krill oil
Placebo
Arm Description
Fish oil 4 g/day
Krill oil 4g/day
Vegetable oil 4g/day
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
Blood sample
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
Force steadiness during submaximal isometric knee extensor contractions
Measured by using intramuscular iEMG
Neuromuscular Junction (NMJ)
Measured by iEMG
Change in gait speed
Time taken to walk 4 metres at a normal walking pace
Change in Chair rise time
A 30-second sit-to-stand test measured functional abilities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05869526
Brief Title
A Comparison of the Effects of Krill Oil and Fish Oil Supplementation on Muscle Function in Older Adults
Official Title
A Comparison of the Effects of Krill Oil and Fish Oil Supplementation on Muscle Function in Older Adults: a Randomised Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 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
The aim of the study is to compare the effects of Krill Oil and Fish Oil supplementation on muscle function in older adults. The secondary aim is to investigate the mechanisms underlying the beneficial effects previously observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
muscle mass, strength, omega-3, ageing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1:1 basis
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Supplements will be identical in look and taste
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
Fish oil 4 g/day
Arm Title
Krill oil
Arm Type
Active Comparator
Arm Description
Krill oil 4g/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vegetable oil 4g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
EPA rich fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Kril 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 16 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 16 weeks
Title
Change in lean mass
Description
Whole body lean mass measured by measured via bio-electrical impedance
Time Frame
Change from baseline to 16 weeks
Title
Blood sample
Description
Red Blood Cell Omega-3 levels
Time Frame
Change from baseline to 16 weeks
Title
Change in Grip strength
Description
Grip strength measured with a hand held dynamometer
Time Frame
Change from baseline to 16 weeks
Title
Change in Muscle thickness
Description
Vastus lateralis muscle thickness measured by ultrasound
Time Frame
Change from baseline to 16 weeks
Title
Force steadiness during submaximal isometric knee extensor contractions
Description
Measured by using intramuscular iEMG
Time Frame
Change from baseline to 16 weeks
Title
Neuromuscular Junction (NMJ)
Description
Measured by iEMG
Time Frame
Change from baseline to 16 weeks
Title
Change in gait speed
Description
Time taken to walk 4 metres at a normal walking pace
Time Frame
Change from baseline to 16 weeks
Title
Change in Chair rise time
Description
A 30-second sit-to-stand test measured functional abilities
Time Frame
Change from baseline to 16 weeks
Other Pre-specified Outcome Measures:
Title
Step Time (Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Cycle Time (Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Step Length (CM)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Stride Length (CM)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
H-H Base Support (CM)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Single Support (%GC)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Double Support (%GC)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Swing (%GC)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Stance (%GC)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Step/ Extremity Ratio
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Toe In/ Out (deg)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Distance (CM)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Ambulation Time (Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Velocity (CM/Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Mean Normalized Velocity
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Number of Steps
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Cadence (Steps/Min)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Step Time Differential (Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Step Length Differential (CM)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
Title
Cycle Time Differential (Sec)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older adults (aged 60 years or older). BMI less than 30kg/m2
Exclusion Criteria:
Participants (diagnosed and being treated for a pre-existing medical condition (cancer, kidney disease, liver disease, diabetes mellitus and cardiovascular disease, uncontrolled hypertension, gait disturbances limiting the ability to perform assessments of muscle function, dementia, affecting muscles known to use drugs (e.g., steroids). History of allergy to fish or fish oil and regular consumption of more than1portion of oily fish per week or use of fish oil or krill oil supplements will also be excluded.
Facility Information:
Facility Name
Stuart Robert Gray
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart R Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Phone
01413302569
Ext
Gray
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Stuart R Gray, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of the Effects of Krill Oil and Fish Oil Supplementation on Muscle Function in Older Adults
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