NCT06939244

Brief Summary

1\. What will happen to me if I take part? All study visits will be at the University of Glasgow main campus within the Sir James Black building. Initial visit (duration 1 hours) We will ask that for each study visit you come to the laboratory with clothing suitable to exercise in (loose shorts) for your own comfort and to also make it easier for us to complete certain measurements where access to upper legs will be necessary. Changing facilitates will be provided on-site. After the screening process, your physical activity and your diet will be assessed via questionnaires. We will then familiarise you with the physical function tests and neuromuscular measurements. Visit 2 (duration 1 hours) Before the remaining study visits in the morning, you will be asked to arrive at the laboratory after an overnight fast (no food or caffeinated/calorific beverages from 10pm), and without having done intense exercise for two days prior to the visit. Upon arriving in the laboratory, we will collect a blood sample (after which we will provide you with a snack), and measure your body composition, muscle size, muscle strength and physical function. You will then be familiarised with the resistance training protocol, and we will determine your maximum strength for two leg exercises. After these measurements are completed, we will randomly assign you to consumed 2g/day of either krill oil or a mixed vegetable oil. Visit 3 (duration 3 hours) After 8 weeks of supplementation, you will attend for a third study visit. This will involve a blood sample and repeating the same measures from the baseline visit with the addition of a measurement of soreness in the upper legs. We will then ask you to complete muscle-damaging exercises consisting of a warm-up of 5 minutes of downhill walking (5% decline at a self selected speed between 3-6 km/h) followed by 4 sets of machine exercises of both leg kicking and leg pushes. These leg exercises will be performed at \~70% of your maximum strength and we will ask you to perform as many repetitions as you can, with the last two sets of each exercise also consisting of 4 extra lowering repetitions. Five minutes and 60 minutes following the muscle-damaging exercise, all the measurements, including blood samples, will be repeated. Visit 4 (duration 1 hours) Two days after visit 3, we will once again repeat the measures taken on visit 3 for a final time. Measurements Blood sample: A blood sample (15ml) will be collected from a vein in your arm by a trained member of the research team. Muscle size: We will use an ultrasound to assess muscle thickness of one of the muscles on the outside of your legs. Muscle strength: You will sit in a chair with your legs at a 90-degree angle. A strap will be placed around the right ankle which will be connected to a force sensor and three sticky surface electrodes will be placed on your thigh. We will then ask you to contract as hard as you can with the leg fixed in position, and we will record the force for 5 seconds. You will perform 3 contractions, with a 1min rest between contractions. After the maximal contractions, will be ask you to contract at 20, 35 and 50% of your maximal effort for 15 seconds so that we can record electrical activity in your muscle. We will then stimulate a contraction with a small electrical current at rest and during a maximal contraction. We will also measure grip strength, making 3 measures from each hand. We will measure your strength on exercise machines, for both leg kicking and leg pushing. Following a warm-up, the weights on each machine will be progressively increased in until you cannot do any more. Physical function: We will ask you to rise from a chair 5 times and to walk a distance of 4 metres and record how long this takes. We will also ask you to stand for 10 seconds with your legs in 3 different positions. These will be demonstrated to you before you do this. Body composition: We will measure total fat and lean mass using bioelectrical impedance analysis. Soreness: We will ask you to mark on a line how sore your muscle feels to measure muscle soreness before and immediately after the muscle damage protocol in two different tests. In the first test, we will apply a fixed, moderate amount of pressure on your thigh and we will ask you how sore it feels; in the second test, we will apply an increasing amount of pressure until on your thigh until you tell us it feels sore.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 22, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 25, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

Omega-3ExerciseMuscle

Outcome Measures

Primary Outcomes (3)

  • Muscle soreness (Habitual Soreness)

    Visual Analogue Scales will be used to measure muscle soreness before and immediately after the muscle damage protocol. This assessment with a visual analogue scale will be done after asking the participant to sit down and stand up from a chair twice to determine muscle soreness during habitual physical activity.

    0 to 48 hours (Post Intervention)

  • Muscle soreness (Pain Pressure Threshold)

    Visual Analogue Scales will be used to measure muscle soreness before and immediately after the muscle damage protocol. This assessment, with a visual analogue scale and handheld soreness pressure algometer, will determine the pressure threshold required to cause soreness and will be taken at the site which is 10% of the circumference laterally from the mid-point between the iliac crest and the top of the patella.

    0 to 48 hours (Post Intervention)

  • Muscle soreness (5kg/cm2)

    Visual Analogue Scales will be used to measure muscle soreness before and immediately after the muscle damage protocol. This assessment with a visual analogue scale and handheld soreness pressure algometer will be in response to 5kg/cm2 of pressure delivered at 10% of the circumference laterally from the mid-point between the iliac crest and the top of the patella.

    0 to 48 hours (Post Intervention)

Secondary Outcomes (19)

  • Fatty Acid Composition

    From enrollment to the end of treatment at 8 weeks

  • Muscle size

    From enrollment to the end of treatment at 8 weeks

  • Knee Extensor Strength

    From enrollment to the end of treatment at 8 weeks

  • Fat mass

    From enrollment to the end of treatment at 8 weeks

  • Grip Strength

    From enrollment to the end of treatment at 8 weeks

  • +14 more secondary outcomes

Study Arms (2)

Krill oil Supplement

EXPERIMENTAL

2g of Krill oil per day

Dietary Supplement: Krill oil

Mixed Vegetable Oil

PLACEBO COMPARATOR

2g of Mixed Vegetable Oil per day

Dietary Supplement: Krill oil

Interventions

Krill oilDIETARY_SUPPLEMENT

Krill oil supplement

Krill oil SupplementMixed Vegetable Oil

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 60 years old or older
  • Have a BMI of less than 30kg/m2
  • Participating in resistance-type exercise for less than 1h per week

You may not qualify if:

  • Diabetes
  • Severe cardiovascular disease defined as arrythmia, valve disease, coronary artery disease, heart failure, peripheral arterial disease, cerebrovascular disease, congenital heart disease or myocardial infarct.
  • Seizure disorders
  • Uncontrolled hypertension (blood pressure higher than 150/90mmHg at baseline measurement)
  • Cancer or cancer that has been in remission for less than 5 years
  • Ambulatory impairments limiting the ability to perform muscle function assessments
  • Dementia
  • Taking medications known to affect muscle (like steroids)
  • Having an implanted electronic device (such as a pacemaker, defibrillator, or insulin pump)
  • Allergies to seafood
  • Regular consumption of more than one portion of oily fish per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, Other, G12 8TA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Stuart Gray

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 22, 2025

Study Start

February 1, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

April 22, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations