University of Stirling
Stirling, Stirlingshire, FK9 4LA, United Kingdom
NCT Number: NCT04772040
In this 5-month study, we will track the incorporation and washout of n-3 PUFA into different tissues following two different dosing strategies in healthy young and older volunteers. All groups will be followed for washout.
Data gathered from this study will be used to establish novel dosing strategies and provide insights into the incorporation of n-3 PUFAs in different tissues and their washout in young and older participants.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stirling, Stirlingshire, FK9 4LA, United Kingdom
Skeletal muscle is crucial for health and accounts for approximately 40% of total body mass. A loss of skeletal muscle mass is seen in the process of ageing, with reductions between 0.2%-0.5% of muscle mass per year starting in the fifth decade. Accelerated loss of muscle and function above a certain threshold is characterized as sarcopenia. Age-related sarcopenia is prevalent in the UK; it is estimated to affect 4.6% men and 7.9% women with an average age of 67 years. Older people have an impaired capacity to increase muscle protein synthesis (MPS) rates in response to protein intake; this is thought to be a key contributor to age-related sarcopenia. Therefore, it is essential to elucidate new strategies to prevent and treat the accelerated loss of muscle mass and function.
Omega (ω)-polyunsaturated fatty acids (n-3 PUFAs) derived from fish oil have possible beneficial effects on health. Evidence suggests potential therapeutic effects of n-3 PUFAs in maintenance/prevention of loss of skeletal muscle mass. N-3 PUFAs probably exert their effects by incorporation into tissue membranes. However, the relation between dose and incorporation into tissue membranes is unclear. Interestingly, a higher dose ingested over 4 weeks seen by McGlory et al. induced similar omega-3 incorporation in the tissue compared to the low doses over 8 weeks studied by Smith et al. If higher doses change tissue composition earlier, then there will be earlier benefits for muscle health and function. Thus, there is a need to examine whether an initial loading dose incorporation into tissues can be sustained by moving to a lower maintenance feeding dose. Furthermore, the exact molecular mechanisms of how n-3 PUFAs act on skeletal muscle are unclear. Several metabolic and molecular responses are affected, but wherein these pathways n-3 PUFAs act remain largely unknown and requires more investigation, with a focus on long-term settings.
This study aims to tackle these problems by executing a 5-month study where we will track the incorporation and washout of n-3 PUFAs into different tissues following two different dosing strategies in healthy young and older volunteers. Data gathered from this study will be used to establish novel dosing strategies and provide insights into the incorporation of n-3 PUFAs in different tissues and their washout in young and older participants. Ultimately, these insights will help targeting, prevention, and treatment of sarcopenia.
Participating in this study requires approximately 30 hours of commitment, of which 12 hours will be spent in the lab.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fish oil capsules.
Time frame: Screening, Baseline (0 weeks), 4 weeks, 6 weeks, 8 weeks, 12 weeks (post intervention), 14 weeks, 16 weeks, 20 weeks (post wash-out)
Changes in red blood cell membrane lipid composition by collecting venous blood samples.
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Changes in skeletal muscle lipid composition by performing a muscle tissue biopsy in the vastus lateralis.
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Changes in adipose lipid composition by performing an adipose tissue biopsy in the abdominal region.
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Secondary outcome from the skeletal muscle biopsy will focus on the measurement of the phosphorylation status of signaling proteins known to regulate protein synthesis and breakdown.
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Secondary outcome from the adipose tissue biopsy will focus on markers involved in inflammation (e.g. NF-kB, IL-6)
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Secondary outcome measures from red blood cells will focus on mediators derived from lipid and changes in lipid mediator synthesis.
Time frame: Baseline (0 weeks), 12 weeks (post-intervention), 20 weeks (post wash-out)
Body composition will be estimated using dual energy X-ray absorptiometry (DEXA) scan.
Time frame: Baseline (0 weeks), 12 weeks (post-intervention), 20 weeks (post wash-out)
Subcutaneous fat will be assessed with the sum of skinfold thicknesses from 8 sites, following the ISAK protocol.
Time frame: Screening (baseline, 0 weeks), 8 weeks, 16 weeks.
Muscle strength is determined by performing the handgrip strength test.
Time frame: Screening (baseline, 0 weeks), 8 weeks, 16 weeks.
Muscle mobility is determined by performing the timed-up-and-go test.
University of Stirling
Other
Impact of Omega (ω)-3 Polyunsaturated Fatty Acids (n-3 PUFA) Upon Blood, Muscle and Adipose Tissue Content and Function: Dosing and Washout Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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