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CompletedNCT04772040Updated Dec 4, 2023

Impact of Fish Oil Dose on Tissue Content and Function

An interventional study of Fish oil supplementation in Aging, Sarcopenia and Muscle Atrophy, sponsored by University of Stirling. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by University of Stirling · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Aging
  • Sarcopenia
  • Muscle Atrophy

Keywords

  • Omega-3 polyunsaturated fatty acids
  • Fish oil supplementation
  • Washout
  • Dosing strategy
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of Stirling is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provide valid informed consent prior to any study procedure
  • Males and females 18-35 years of age or 60+ years of age
  • BMI between 18-29 kg/m2
  • Free of musculoskeletal injuries
  • Willing to avoid alcohol in the 48-h period prior to the visits
  • Willing to sustain their current diet and lifestyle and not to make conscious changes for the duration of the study
  • An omega-3 status of less than 20% seen in whole blood taken during the screening visit.
  • Willing to sustain current use of supplementation/anti-depressants or other medication not interfering with the study results.
  • Women: not currently pregnant, not intending to become pregnant in the coming 5 months or lactating.
  • Women: willing to maintain current use of contraceptives or post-menopausal supplementation if any for the duration of the study.
  • Not allergic to fish, shellfish, seaweed, iodine, anesthetics, nickel or chrome.

Exclusion criteria

Exclusion Criteria:

  • Smoker
  • Adherence to a strict vegan/vegetarian diet
  • Treatment for cardiovascular diseases or blood pressure >140/90 mmHg
  • Any diseases or medication that cause fat malabsorption (intestine issues such as celiac disease, Crohn's disease,chronic pancreatitis, or cystic fibrosis; liver and biliary disease, diarrhoea, steatorrhea)
  • Diabetes or other (metabolic) disease that induce muscle wasting
  • Surgery in prior 6 months
  • Currently being on FO supplementation
  • Current participation in another clinical trial, or in a trial within the past month
  • For women: pregnant, intention to get pregnant during the course of the study or lactating
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Young loading dose group

    Participants (18-35) will receive a loading dose of fish oil supplementation during the first 4 weeks of the intervention period of the study. In the last 8 weeks participants will receive a maintenance dose of fish oil supplementation. The total amount of EPA/DHA received throughout the supplementation period will be the same as the old group.

    Dietary Supplement: Fish oil supplementation

  • Experimental
    Old loading dose group

    Participants (60y+) will receive a loading dose of fish oil supplementation during the first 4 weeks of the intervention period of the study. In the last 8 weeks participants will receive a maintenance dose of fish oil supplementation. The total amount of EPA/DHA received throughout the supplementation period will be the same as the young group.

    Dietary Supplement: Fish oil supplementation

  • Experimental
    Young constant dose group

    Participants (18-35y) will receive a constant dose of fish oil supplementation throughout the intervention period of the study. Total amount of EPA/DHA received throughout the 12 weeks supplementation period will be the same as the loading groups.

    Dietary Supplement: Fish oil supplementation

  • Experimental
    Old constant dose group

    Participants (60y+) will receive a constant dose of fish oil supplementation throughout the intervention period of the study. Total amount of EPA/DHA received throughout the 12 weeks supplementation period will be the same as the loading groups.

    Dietary Supplement: Fish oil supplementation

Interventions

  • Dietary supplementFish oil supplementation

    Fish oil capsules.

06

What researchers measure

Primary outcomes

  1. Red blood cell lipid composition

    Changes in red blood cell membrane lipid composition by collecting venous blood samples.

    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)

  2. Skeletal muscle lipid composition

    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)

  3. Adipose tissue lipid composition

    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 outcomes

  1. Skeletal muscle tissue biopsy muscle protein turnover markers

    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)

  2. Adipose tissue biopsy inflammation markers

    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)

  3. Red blood cell lipid mediator markers

    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), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)

Other outcomes

  1. Body composition DEXA scan.

    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)

  2. Subcutaneous fat determination.

    Subcutaneous fat will be assessed with the sum of skinfold thicknesses from 8 sites, following the ISAK protocol.

    Time frame: Baseline (0 weeks), 12 weeks (post-intervention), 20 weeks (post wash-out)

  3. Strength measures

    Muscle strength is determined by performing the handgrip strength test.

    Time frame: Screening (baseline, 0 weeks), 8 weeks, 16 weeks.

  4. Mobility measures

    Muscle mobility is determined by performing the timed-up-and-go test.

    Time frame: Screening (baseline, 0 weeks), 8 weeks, 16 weeks.

07

Study locations

1 site
  • University of Stirling
    Stirling, Stirlingshire FK9 4LA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04772040
Lead sponsor
University of Stirling
Collaborators
Danone Nutricia Research
Responsible party
Milena Banic (PhD Researcher, University of Stirling) — Principal investigator
First posted
Feb 26, 2021
Start date
Nov 1, 2021
Primary completion
Jun 15, 2023
Completion
Jun 15, 2023
Last update
Dec 4, 2023

Study contacts

Milena Banic, Msc
principal investigator · University of Stirling
Nidia Rodriguez-Sanchez, PhD
study director · University of Stirling
Stuart Galloway, PhD
study director · University of Stirling
Oliver Witard, PhD
study director · King's College London
Miriam van Dijk-Ottens, PhD
study director · Danone Nutricia Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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