Investigating the Feasibility of Krill Oil Intervention to Improve Muscle Function in Adults With Long-term Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Glasgow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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]).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Krill oil supplementation
Dietary supplementKrill oil supplementation program providing 4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
Control
Dietary supplementVegetable oil supplementation (4 g/day)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Krill Oil groupExperimental treatment 1 intervention
Group B: Arm 2: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Grip strength
Measured using a handgrip dynamometer
Time frame
Changes from baseline to week 12Secondary outcomes
1
Knee extendor Strength
Knee extensor maximal torque measured during an isometric maximal voluntary contraction (MVC)
Time frame
Changes from baseline to week 122
Muscle size, assessed as vastus lateralis muscle thickness by ultrasound
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.
Time frame
Changes from baseline to week 123
Gait speed
Gait speed will be assessed as a measure of physical function.
Time frame
From baseline to week 124
Fatty Acid Composition
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.
Time frame
From baseline to week 12Sponsors and contacts
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Source ClinicalTrials.gov