- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296875
The Krill Ageing Muscle Mechanisms (KAMM) Study (KAMM)
Uncovering the Mechanisms Through Which Krill Oil Increases Muscle Function in Older Adults.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stuart Gray
- Phone Number: +441413302569
- Email: stuart.gray@glasgow.ac.uk
Study Locations
-
-
-
Glasgow, United Kingdom
- Recruiting
- University of Glasgow
-
Contact:
- Stuart R Gray, PhD
- Phone Number: 01413302569
- Email: stuart.gray@glasgow.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
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
4g/day vegetable oil for 24 weeks
|
mixed vegetable oil
|
|
Active Comparator: Krill oil
4/g/day krill oil for 24 weeks
|
Krill oil
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip strength
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Neuromuscular junction transmission instability
Time Frame: Change from baseline to 24 weeks
|
We will assess peripheral motor unit (MU) characteristics in the vastus lateralis muscle using intramuscular electromyography
|
Change from baseline to 24 weeks
|
|
Gait speed
Time Frame: Change from baseline to 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extensor maximal torque
Time Frame: Change from baseline to 24 weeks
|
We will measure the muscle strength of the knee extensor muscles during a maximal voluntary contraction (MVC)
|
Change from baseline to 24 weeks
|
|
Vastus lateralis muscle cross sectional area
Time Frame: Change from baseline to 24 weeks
|
We will measure this using ultrasound
|
Change from baseline to 24 weeks
|
|
Vastus lateralis pennation angle
Time Frame: Change from baseline to 24 weeks
|
We will measure this using ultrasound
|
Change from baseline to 24 weeks
|
|
Vastus lateralis fascicle length
Time Frame: Change from baseline to 24 weeks
|
We will measure this using ultrasound
|
Change from baseline to 24 weeks
|
|
Erythrocyte fatty acid composition
Time Frame: Change from baseline to 24 weeks
|
Blood samples (15 ml each visit) will be collected
|
Change from baseline to 24 weeks
|
|
Knee extensor force steadiness
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Hand flexor muscles intermuscular coherence
Time Frame: Change from baseline to 24 weeks
|
Intermuscular coherence will be measured for 1 min on 20% of MVC using sEMG electrodes.
|
Change from baseline to 24 weeks
|
|
Cortico-muscular coherence between sensory motor cortex and hand extensor muscles
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Femoral Nerve Stimulation
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Transcranial Magnetic Stimulation (TMS)
Time Frame: Change from baseline to 24 weeks
|
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
|
|
TMS Inhibition
Time Frame: Change from baseline to 24 weeks
|
corticomotor inhibition during the MVCs a single TMS stimulation will be delivered over the motor cortex.
|
Change from baseline to 24 weeks
|
|
TMS Excitation
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Gait characteristics during 4m walk test and the timed up and go test
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Gait cycle with leg support parameters
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Vastus lateralis motor unit conduction velocity
Time Frame: Change from baseline to 24 weeks
|
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
|
|
Vastus lateralis and vastus medialis intramuscular coherence
Time Frame: Change from baseline to 24 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAMM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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