The Krill Ageing Muscle Mechanisms (KAMM) Study

Sarcopenia Clinical Trial

— KAMM  

Official title:

Uncovering the Mechanisms Through Which Krill Oil Increases Muscle Function in Older Adults.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296875
• Other study ID #: KAMM
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Sarcopenia

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