Investigating the Feasibility of Krill Oil Intervention to Improve Muscle Function in Adults With Long-term Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Krill oil supplementation, Control.
- Who it may be relevant to
- Registry conditions: Krill Oil, Muscle Function, Grip Strength, Long-Term Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Krill Oil Supplementation on Muscle Function in Adults With High-risk Long-term Conditions: a Randomized Controlled Pilot Study.
Overview
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.
Interventions
- Dietary supplement Krill oil supplementation
Krill oil supplementation program providing 4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks. - Dietary supplement Control
Vegetable oil supplementation (4 g/day)
Primary outcome measures
- Grip strength [Time frame: Changes from baseline to week 12]
Secondary outcome measures (11)
- Knee extendor Strength [Time frame: Changes from baseline to week 12]
- Muscle size, assessed as vastus lateralis muscle thickness by ultrasound [Time frame: Changes from baseline to week 12]
- Gait speed [Time frame: From baseline to week 12]
- Fatty Acid Composition [Time frame: From baseline to week 12]
- Inflammatory and metabolic markers [Time frame: From baseline to week 12]
- Height [Time frame: Changes from baseline to week 12]
- Bodyweight [Time frame: Changes from baseline to week 12]
- Body Mass Index (BMI) [Time frame: Changes from baseline to week 12]
- Body Fat Mass [Time frame: Changes from baseline to week 12]
- Body Fat Percentages [Time frame: Changes from baseline to week 12]
- Fat Free Mass [Time frame: Changes from baseline to week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United Kingdom · 2 centers
- Lab 242, Sir James Black Building, University of Glasgow — Glasgow
- University of Glasgow — Glasgow
Identifiers
NCT: NCT07130513 · KOMM