- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07130513
- Original Trial
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Professor Stuart Gray
- Phone Number: +441413302569
- Email: stuart.gray@glasgow.ac.uk
Study Locations
-
-
Lanarkshire
-
Glasgow, Lanarkshire, United Kingdom, G12 8TA
- Recruiting
- Lab 242, Sir James Black Building, University of Glasgow
-
Contact:
- Marion Guerrero
- Phone Number: 07922634654
- Email: marion.g.wyss@gmail.com
-
Contact:
- Lynsey Johnston
- Phone Number: 01413306287
- Email: Lynsey.Johnston@glasgow.ac.uk
-
Principal Investigator:
- Stuart R Gray
-
Glasgow, Lanarkshire, United Kingdom, G12 8TA
- Not yet recruiting
- University of Glasgow
-
Contact:
- Stuart Gray
- Phone Number: 01413302569
- Email: stuart.gray@glasgow.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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]).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Krill Oil group
4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
|
Krill oil supplementation program providing 4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
Other Names:
|
|
Placebo Comparator: Arm 2: Control group
4 g/day of placebo (vegetable oil capsules) for 12 weeks.
|
Vegetable oil supplementation (4 g/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip strength
Time Frame: Changes from baseline to week 12
|
Measured using a handgrip dynamometer
|
Changes from baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extendor Strength
Time Frame: Changes from baseline to week 12
|
Knee extensor maximal torque measured during an isometric maximal voluntary contraction (MVC)
|
Changes from baseline to week 12
|
|
Muscle size, assessed as vastus lateralis muscle thickness by ultrasound
Time Frame: Changes from baseline to week 12
|
The investigators will assess vastus lateralis muscle thickness using B-mode ultrasound, with participants in a supine position.
This measurement will also serve as an indirect indicator of muscle damage through cell swelling.
The measurement site will be located at 10% of the thigh circumference lateral to the midpoint between the iliac crest and the superior border of the patella.
|
Changes from baseline to week 12
|
|
Gait speed
Time Frame: From baseline to week 12
|
Gait speed will be assessed as a measure of physical function.
|
From baseline to week 12
|
|
Fatty Acid Composition
Time Frame: From baseline to week 12
|
A venous blood sample (15 ml) will be collected from an antecubital vein by a trained member of the research team and analysed for erythrocyte fatty acid profile.
|
From baseline to week 12
|
|
Inflammatory and metabolic markers
Time Frame: From baseline to week 12
|
A venous blood sample (15 ml) will be collected by a trained member of the research team from an antecubital vein and analysed to estimate plasma glucose, lipids (triacylglycerol, total cholesterol, HDL), and markers of inflammation (e.g., hsCRP, IL-6, TNF-α, homocysteine).
|
From baseline to week 12
|
|
Height
Time Frame: Changes from baseline to week 12
|
Height recorded using a stadiometer in centimetre at the beginning of the study.
|
Changes from baseline to week 12
|
|
Bodyweight
Time Frame: Changes from baseline to week 12
|
Changes in bodyweight, recorded in kilogram.
Measured via body composition analyser.
|
Changes from baseline to week 12
|
|
Body Mass Index (BMI)
Time Frame: Changes from baseline to week 12
|
Will be calculated from the bodyweight (in kilogram) and height (in meter) according to the BMI formula (kg/m^2).
|
Changes from baseline to week 12
|
|
Body Fat Mass
Time Frame: Changes from baseline to week 12
|
Changes in body fat mass, recorded in kilogram.
Measured via body composition analyser.
|
Changes from baseline to week 12
|
|
Body Fat Percentages
Time Frame: Changes from baseline to week 12
|
Changes in body fat percentage, recorded in percentage.
Measured via body composition analyser.
|
Changes from baseline to week 12
|
|
Fat Free Mass
Time Frame: Changes from baseline to week 12
|
Changes in fat free mass, recorded in kilogram.
Measured via body composition analyser.
|
Changes from baseline to week 12
|
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOMM
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
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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