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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06296875
Other study ID # KAMM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date March 2026

Study information

Verified date June 2024
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length). Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy. Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - body mass index (BMI) </= 30 kg/m2 - Age >/= 65 years - Capacity to consent - Living within the Glasgow area Exclusion Criteria: - Diabetes mellitus - Severe cardiovascular disease - Seizure disorders - Uncontrolled hypertension (>150/90mmHg) - Active cancer or cancer that has been in remission <5 years - Participation in any resistance exercise training within the last 6 months - Impairments which may limit ability to perform assessments of muscle function - Dementia - Fish/shellfish allergy - Taking medication known to affect muscle (e.g. steroids, Selective serotonin reuptake inhibitors) or anticoagulants (e.g. warfarin) - Taking omega-3 supplements in the last 3 months - Regularly consuming 1 or more portions of oily fish per week - Not able to understand English

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vegetable oil
mixed vegetable oil
Krill oil
Krill oil

Locations

Country Name City State
United Kingdom University of Glasgow Glasgow

Sponsors (1)

Lead Sponsor Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Grip strength We will measure grip strength using a handgrip dynamometer, making 3 maximal contractions in each hand, with the dominant hand recorded. The highest grip strength will be used in analysis. Change from baseline to 24 weeks
Primary Neuromuscular junction transmission instability We will assess peripheral motor unit (MU) characteristics in the vastus lateralis muscle using intramuscular electromyography Change from baseline to 24 weeks
Primary Gait speed We will measure gait speed using a gaitrite connected mat during a 4 m walk test and the timed up and go test at usual speed. Change from baseline to 24 weeks
Secondary Knee extensor maximal torque We will measure the muscle strength of the knee extensor muscles during a maximal voluntary contraction (MVC) Change from baseline to 24 weeks
Secondary Vastus lateralis muscle cross sectional area We will measure this using ultrasound Change from baseline to 24 weeks
Secondary Vastus lateralis pennation angle We will measure this using ultrasound Change from baseline to 24 weeks
Secondary Vastus lateralis fascicle length We will measure this using ultrasound Change from baseline to 24 weeks
Secondary Erythrocyte fatty acid composition Blood samples (15 ml each visit) will be collected Change from baseline to 24 weeks
Secondary Knee extensor force steadiness During the contractions to measure NMJ transmission instability we will also calculate force steadiness, as a measure of neuromuscular control Change from baseline to 24 weeks
Secondary Vastus lateralis motor unit conduction velocity will be measured using High Density surface electromyography (HDsEMG) during submaximal (10%, 30%, 50% and 70% of MVC) and during the MVC Change from baseline to 24 weeks
Secondary Vastus lateralis and vastus medialis intramuscular coherence Motor unit spike train will be measured using the surface electromyography (sEMG) electrodes while participants exert 20% of maximum voluntary contraction Change from baseline to 24 weeks
Secondary Hand flexor muscles intermuscular coherence Intermuscular coherence will be measured for 1 min on 20% of MVC using sEMG electrodes. Change from baseline to 24 weeks
Secondary Cortico-muscular coherence between sensory motor cortex and hand extensor muscles Cortico-muscular coherence is a derived measure, based on measurement of the electroencephalography (EEG) and motor unit spikes. EEG electrodes will be placed over the motor area of hands and worn during hand contractions Change from baseline to 24 weeks
Secondary Femoral Nerve Stimulation Single stimuli will be delivered to the muscle while participants maintain a 20% MVC isometric contraction, and the intensity of stimulation was increased until a plateau in twitch amplitude and rectus femoris M-wave (Mmax) occurs. Supramaximal stimulation will then be delivered by increasing the final stimulator output intensity by a further 30%. Change from baseline to 24 weeks
Secondary Transcranial Magnetic Stimulation (TMS) Motor evoked potentials (MEPs) will be elicited in the rectus femoris of the dominant leg via single pulse TMS and assessed using electromyographic (EMG) recordings. Change from baseline to 24 weeks
Secondary TMS Inhibition corticomotor inhibition during the MVCs a single TMS stimulation will be delivered over the motor cortex. Change from baseline to 24 weeks
Secondary TMS Excitation For assessment of corticospinal excitability, participants will maintain a 20% MVC isometric contraction while 20 single TMS pulses, separated by 6 s, will be delivered over the motor cortex Change from baseline to 24 weeks
Secondary Gait characteristics during 4m walk test and the timed up and go test The 4 m walk test involves participants walking a 4m distance at a normal walking pace, walking through the 4m line at the end of the gaitrite mat. The Timed Up and Go test (timed version of the Get Up and Go test) involves the participant sitting on a chair getting up, walking 3 meters in front of them across the gaitrite mat, returning to the chair and sitting down. The Theia markerless system will be used to extract Gait parameters Change from baseline to 24 weeks
Secondary Gait cycle with leg support parameters We will also get posture information from the 3D skeleton measurements and balance (pitch and roll) which are important in assessing fall risks and functional gait. Change from baseline to 24 weeks
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