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Investigating the Feasibility of Krill Oil Intervention to Improve Muscle Function in Adults With Long-term Conditions

Not Applicable
Not yet recruiting
Conditions
Krill Oil
Muscle Function
Grip Strength
Long-Term Conditions
Omega 3 Fatty Acids
Registration Number
NCT07130513
Lead Sponsor
University of Glasgow
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Grip strengthChanges from baseline to week 12

Measured using a handgrip dynamometer

Secondary Outcome Measures
NameTimeMethod
Knee extendor StrengthChanges from baseline to week 12

Knee extensor maximal torque measured during an isometric maximal voluntary contraction (MVC)

Muscle size, assessed as vastus lateralis muscle thickness by ultrasoundChanges 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.

Gait speedFrom baseline to week 12

Gait speed will be assessed as a measure of physical function.

Fatty Acid CompositionFrom 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.

Inflammatory and metabolic markersFrom 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).

HeightChanges from baseline to week 12

Height recorded using a stadiometer in centimetre at the beginning of the study.

BodyweightChanges from baseline to week 12

Changes in bodyweight, recorded in kilogram. Measured via body composition analyser.

Body Fat PercentagesChanges from baseline to week 12

Changes in body fat percentage, recorded in percentage. Measured via body composition analyser.

Body Mass Index (BMI)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).

Body Fat MassChanges from baseline to week 12

Changes in body fat mass, recorded in kilogram. Measured via body composition analyser.

Fat Free MassChanges from baseline to week 12

Changes in fat free mass, recorded in kilogram. Measured via body composition analyser.

Trial Locations

Locations (1)

University of Glasgow

🇬🇧

Glasgow, Lanarkshire, United Kingdom

University of Glasgow
🇬🇧Glasgow, Lanarkshire, United Kingdom
Stuart Gray
Contact
01413302569
stuart.gray@glasgow.ac.uk

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