- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869513
Krill Oil and Resistance Exercise in Older Adults (KOREA)
March 25, 2025 updated by: Stuart Gray, University of Glasgow
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
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 |
|---|---|
|
Placebo Comparator: Vegetable oil + Resistance exercise
4g/day vegetable oil and home based resistance exercise for 16 weeks
|
Mixed vegetable oil
Home based resistance band and body weight exercise
|
|
Active Comparator: Krill oil + Resistance exercise
4g/day krill oil and home based resistance exercise for 16 weeks
|
Home based resistance band and body weight exercise
Superba Krill Oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nueromuscular Junction (NMJ) transmission instability
Time Frame: Change from baseline to 16 weeks
|
NMJ transmission instability will be measured by iEMG
|
Change from baseline to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extensor maximal torque
Time Frame: Change from baseline to 8 16 weeks
|
Knee extensor maximal torque will be measured by a load cell
|
Change from baseline to 8 16 weeks
|
|
30s chair stand test
Time Frame: Change from baseline to 16 weeks
|
measuring the functional abilities
|
Change from baseline to 16 weeks
|
|
Gait speed
Time Frame: Change from baseline to 16 weeks
|
measuring the functional abilities
|
Change from baseline to 16 weeks
|
|
Force steadiness during submaximal isometric knee extensor contractions
Time Frame: Change from baseline to 16 weeks
|
Steadiness of force whilst contracting
|
Change from baseline to 16 weeks
|
|
Red Blood Cell Omega-3 levels
Time Frame: Change from baseline to 16 weeks
|
Change from baseline to 16 weeks
|
|
|
Grip strength
Time Frame: Change from baseline to 16 weeks
|
Grip strength will be measured by handgrip dynamometer
|
Change from baseline to 16 weeks
|
|
Muscle thickness
Time Frame: Change from baseline to 16 weeks
|
Vastus Lateralis muscle thickness will be measured by ultrasound
|
Change from baseline to 16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Support (%GC)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Double Support (%GC)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Swing (%GC)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Stance (%GC)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Step/ Extremity Ratio
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Number of Steps
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Cadence (Steps/Min)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Step Time (sec)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Cycle Time (sec)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Step Length (cm)
Time Frame: Change from baseline to16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to16 weeks
|
|
Stride Length (cm)
Time Frame: Change from baseline to16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to16 weeks
|
|
H-H Base Support (cm)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Toe In / Out (deg)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Distance (cm)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Ambulation Time (sec)
Time Frame: Change from baseline to 16 weeks
|
Change from baseline to 16 weeks
|
|
|
Velocity (cm/sec)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Mean Normalized Velocity
Time Frame: Change from baseline to16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to16 weeks
|
|
Step Time Differential (sec)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Step Length Differential (cm)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 weeks
|
|
Cycle Time Differential (sec)
Time Frame: Change from baseline to 16 weeks
|
Measured during a 4m walk using a gaitrite mat
|
Change from baseline to 16 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)
May 5, 2023
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 11, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOREA
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.