Back to resultsKrill Oil and Resistance Exercise in Older Adults (KOREA)
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vegetable oil
Krill oil
Home-based resistance exercise
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Home exercise, Resistance exercise, Exercise, Krill oil, Muscle strength, Neuromuscular function, Physical function
Eligibility Criteria
Inclusion Criteria: Over the age of 60 years scoring a low level of physical activity based on international physical activity questionnaire (not meeting the recommend physical activity which is at least 600 MET-min per week). Exclusion Criteria: 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 ability to perform assessments of muscle function dementia taking medication known to affect muscle (e.g. steroids) have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump) on anticoagulant therapy allergies to seafood regular consumption of more than 1 portion of oily fish per week already taking fish or krill oil or other n3 PUFA supplements femoral neck fracture or other severe of hip or knee operations stroke Parkinson's disease COPD kidney disease hyperlipidaemia obesity osteoporosis.
Sites / Locations
- University of GlasgowRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Vegetable oil + Resistance exercise
Krill oil + Resistance exercise
Arm Description
4g/day vegetable oil and home based resistance exercise for 16 weeks
4g/day krill oil and home based resistance exercise for 16 weeks
Outcomes
Primary Outcome Measures
Nueromuscular Junction (NMJ) transmission instability
NMJ transmission instability will be measured by iEMG
Secondary Outcome Measures
Knee extensor maximal torque
Knee extensor maximal torque will be measured by a load cell
30s chair stand test
measuring the functional abilities
Gait speed
measuring the functional abilities
Force steadiness during submaximal isometric knee extensor contractions
Steadiness of force whilst contracting
Red Blood Cell Omega-3 levels
Grip strength
Grip strength will be measured by handgrip dynamometer
Muscle thickness
Vastus Lateralis muscle thickness will be measured by ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05869513
Brief Title
Krill Oil and Resistance Exercise in Older Adults
Acronym
KOREA
Official Title
The Effects of Krill Oil Supplementation on Adaptations in Muscle Strength, Function, Mass and Neuromuscular Function to a Pragmatic Home-based Resistance Exercise Intervention in Sedentary Older Adults: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 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 this study is to determine whether krill oil supplementation enhances effects of a pragmatic resistance exercise programme on adaptations in muscle strength, mass, function and neuromuscular function in sedentary older adults. Hypothesis - krill oil supplementation will enhance the beneficial effects of resistance exercise on muscle strength, function, mass and neuromuscular function in sedentary older adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Home exercise, Resistance exercise, Exercise, Krill oil, Muscle strength, Neuromuscular function, Physical function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 parallel group design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All supplements will be matched for taste and look
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vegetable oil + Resistance exercise
Arm Type
Placebo Comparator
Arm Description
4g/day vegetable oil and home based resistance exercise for 16 weeks
Arm Title
Krill oil + Resistance exercise
Arm Type
Active Comparator
Arm Description
4g/day krill oil and home based resistance exercise for 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable oil
Intervention Description
Mixed vegetable oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill oil
Intervention Description
Superba Krill Oil
Intervention Type
Other
Intervention Name(s)
Home-based resistance exercise
Intervention Description
Home based resistance band and body weight exercise
Primary Outcome Measure Information:
Title
Nueromuscular Junction (NMJ) transmission instability
Description
NMJ transmission instability will be measured by iEMG
Time Frame
Change from baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Knee extensor maximal torque
Description
Knee extensor maximal torque will be measured by a load cell
Time Frame
Change from baseline to 8 16 weeks
Title
30s chair stand test
Description
measuring the functional abilities
Time Frame
Change from baseline to 16 weeks
Title
Gait speed
Description
measuring the functional abilities
Time Frame
Change from baseline to 16 weeks
Title
Force steadiness during submaximal isometric knee extensor contractions
Description
Steadiness of force whilst contracting
Time Frame
Change from baseline to 16 weeks
Title
Red Blood Cell Omega-3 levels
Time Frame
Change from baseline to 16 weeks
Title
Grip strength
Description
Grip strength will be measured by handgrip dynamometer
Time Frame
Change from baseline to 16 weeks
Title
Muscle thickness
Description
Vastus Lateralis muscle thickness will be measured by ultrasound
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 to16 weeks
Title
Stride Length (cm)
Description
Measured during a 4m walk using a gaitrite mat
Time Frame
Change from baseline to16 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)
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 to16 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:
Over the age of 60 years
scoring a low level of physical activity based on international physical activity questionnaire (not meeting the recommend physical activity which is at least 600 MET-min per week).
Exclusion Criteria:
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 ability to perform assessments of muscle function
dementia
taking medication known to affect muscle (e.g. steroids)
have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump)
on anticoagulant therapy
allergies to seafood
regular consumption of more than 1 portion of oily fish per week
already taking fish or krill oil or other n3 PUFA supplements
femoral neck fracture or other severe of hip or knee operations
stroke
Parkinson's disease
COPD
kidney disease
hyperlipidaemia
obesity
osteoporosis.
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart R Gray, PhD
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Krill Oil and Resistance Exercise in Older Adults
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