Sarcopenia Clinical Trial
— KOREAOfficial 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
| NCT number | NCT05869513 |
| Other study ID # | KOREA |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 5, 2023 |
| Est. completion date | February 1, 2024 |
| Verified date | May 2023 |
| Source | University of Glasgow |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | February 1, 2024 |
| Est. primary completion date | February 1, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years to 90 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Glasgow | Glasgow |
| Lead Sponsor | Collaborator |
|---|---|
| University of Glasgow |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Step Time (sec) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Cycle Time (sec) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Step Length (cm) | Measured during a 4m walk using a gaitrite mat | Change from baseline to16 weeks | |
| Other | Stride Length (cm) | Measured during a 4m walk using a gaitrite mat | Change from baseline to16 weeks | |
| Other | H-H Base Support (cm) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Single Support (%GC) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Double Support (%GC) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Swing (%GC) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Stance (%GC) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Step/ Extremity Ratio | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Toe In / Out (deg) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Distance (cm) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Ambulation Time (sec) | Change from baseline to 16 weeks | ||
| Other | Velocity (cm/sec) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Mean Normalized Velocity | Measured during a 4m walk using a gaitrite mat | Change from baseline to16 weeks | |
| Other | Number of Steps | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Cadence (Steps/Min) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Step Time Differential (sec) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Step Length Differential (cm) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Other | Cycle Time Differential (sec) | Measured during a 4m walk using a gaitrite mat | Change from baseline to 16 weeks | |
| Primary | Nueromuscular Junction (NMJ) transmission instability | NMJ transmission instability will be measured by iEMG | Change from baseline to 16 weeks | |
| Secondary | Knee extensor maximal torque | Knee extensor maximal torque will be measured by a load cell | Change from baseline to 8 16 weeks | |
| Secondary | 30s chair stand test | measuring the functional abilities | Change from baseline to 16 weeks | |
| Secondary | Gait speed | measuring the functional abilities | Change from baseline to 16 weeks | |
| Secondary | Force steadiness during submaximal isometric knee extensor contractions | Steadiness of force whilst contracting | Change from baseline to 16 weeks | |
| Secondary | Red Blood Cell Omega-3 levels | Change from baseline to 16 weeks | ||
| Secondary | Grip strength | Grip strength will be measured by handgrip dynamometer | Change from baseline to 16 weeks | |
| Secondary | Muscle thickness | Vastus Lateralis muscle thickness will be measured by ultrasound | Change from baseline to 16 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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