Investigating the Feasibility of Krill Oil Intervention to Improve Muscle Function in Adults With Long-term Conditions
KOMM
The Effect of Krill Oil Supplementation on Muscle Function in Adults With High-risk Long-term Conditions: a Randomized Controlled Pilot Study.
1 other identifier
interventional
30
1 country
2
Brief Summary
This study will recruit 30 adults (men and women, aged 18 years and over) who will be randomly assigned to one of two groups in a 12-week double-blind pilot trial. Participants will receive either:
- Arm 1: Krill Oil group: 4 g/day of krill oil supplements (Superba™ Antarctic Krill Oil, 1000 mg capsules), or
- Arm 2: Control group: 4 g/day of placebo (vegetable oil capsules). Participants will be instructed to maintain their usual diet and physical activity patterns throughout the study. Eligibility will be assessed using a health screening questionnaire, completed with the researcher's assistance, before obtaining informed consent. Habitual physical activity will be evaluated using the International Physical Activity Questionnaire (short form), and dietary intake will be assessed with the EPIC Food Frequency Questionnaire (FFQ) at both the beginning and end of the study. In addition, participants will record their fish consumption weekly using a dedicated logbook. Measurements will be taken at baseline and after 12 weeks, including:
- Blood samples to assess inflammatory and metabolic markers.
- Anthropometry and body composition, including weight, height, fat mass, fat percentage, and muscle mass (via ultrasound).
- Muscle strength, measured using handgrip strength and maximal voluntary contraction (each performed three times with rest between attempts).
- Physical performance, assessed with a 4-meter walk test at normal speed Upon completing the study, participants will receive a £50 voucher in appreciation of their contribution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
2 active sites
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
First Submitted
Initial submission to the registry
August 4, 2025
CompletedStudy Start
First participant enrolled
August 18, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
October 2, 2025
October 1, 2025
12 months
August 4, 2025
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Grip strength
Measured using a handgrip dynamometer
Changes from baseline to week 12
Secondary Outcomes (11)
Knee extendor Strength
Changes from baseline to week 12
Muscle size, assessed as vastus lateralis muscle thickness by ultrasound
Changes from baseline to week 12
Gait speed
From baseline to week 12
Fatty Acid Composition
From baseline to week 12
Inflammatory and metabolic markers
From baseline to week 12
- +6 more secondary outcomes
Study Arms (2)
Arm 1: Krill Oil group
EXPERIMENTAL4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
Arm 2: Control group
PLACEBO COMPARATOR4 g/day of placebo (vegetable oil capsules) for 12 weeks.
Interventions
Krill oil supplementation program providing 4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
Eligibility Criteria
You may qualify if:
- Men and women aged ≥18 years who are in the high-risk long-term condition group (having one or more LTCs, including rheumatoid arthritis, gout, type 2 diabetes, coronary heart disease, and stroke \[including transient ischemic attack, TIA\]).
You may not qualify if:
- Participants are diagnosed with and being treated for any type of cancer.
- Presence of neurocognitive disorders or any health condition affecting memory (e.g., Alzheimer's disease, dementia).
- Aortic stenosis, history of haemorrhagic stroke, or presence of aneurysms.
- Current anticoagulant therapy.
- Use of any muscle mass supplements or presence of physiological conditions such as pregnancy or breastfeeding.
- History of allergy to fish or fish oil.
- Regular consumption of more than one portion of oily fish per week, or use of fish oil or krill oil supplements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lab 242, Sir James Black Building, University of Glasgow
Glasgow, Lanarkshire, G12 8TA, United Kingdom
University of Glasgow
Glasgow, Lanarkshire, G12 8TA, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Stuart Gray
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 19, 2025
Study Start
August 18, 2025
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
October 2, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share