AgingNCT04772040
Impact of Fish Oil Dose on Tissue Content and Function
A study testing Fish oil supplementation in people with Aging and Sarcopenia, run by University of Stirling at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Muscle Atrophy
- What is being tested?
- Fish oil supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Stirling
Stirling, Stirlingshire, FK9 4LA
About this study
Official title: Impact of Omega (ω)-3 Polyunsaturated Fatty Acids (n-3 PUFA) Upon Blood, Muscle and Adipose Tissue Content and Function: Dosing and Washout Study
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.
- Conditions
- Aging, Sarcopenia, Muscle Atrophy
- Being tested
- Fish oil supplementation
- Keywords
- Omega-3 polyunsaturated fatty acids, Fish oil supplementation, Washout, Dosing strategy
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil supplementationDietary supplement
Fish oil capsules.
| Study group | Role | What they receive |
|---|---|---|
| Young loading dose group | Experimental | 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. Receives: Dietary Supplement: Fish oil supplementation |
| Old loading dose group | Experimental | 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. Receives: Dietary Supplement: Fish oil supplementation |
| Young constant dose group | Experimental | 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. Receives: Dietary Supplement: Fish oil supplementation |
| Old constant dose group | Experimental | 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. Receives: Dietary Supplement: Fish oil supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell lipid composition
Changes in red blood cell membrane lipid composition by collecting venous blood samples.
Measured: Screening, Baseline (0 weeks), 4 weeks, 6 weeks, 8 weeks, 12 weeks (post intervention), 14 weeks, 16 weeks, 20 weeks (post wash-out)
Skeletal muscle lipid composition
Changes in skeletal muscle lipid composition by performing a muscle tissue biopsy in the vastus lateralis.
Measured: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Adipose tissue lipid composition
Changes in adipose lipid composition by performing an adipose tissue biopsy in the abdominal region.
Measured: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Secondary outcomes (3)
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.
Measured: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
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)
Measured: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
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.
Measured: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Nov 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, parallel design.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia Research
- Responsible party
- Principal investigator, Milena Banic, University of Stirling
- Investigators
- Milena Banic, Msc, Principal investigator, University of StirlingNidia Rodriguez-Sanchez, PhD, Study director, University of StirlingStuart Galloway, PhD, Study director, University of StirlingOliver Witard, PhD, Study director, King's College LondonMiriam van Dijk-Ottens, PhD, Study director, Danone Nutricia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772040
- Sponsor's protocol ID
- 280280
- Status last verified
- Dec 2023
- First submitted
- 4 Nov 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omega (ω)-3 Polyunsaturated Fatty Acids (n-3 PUFA) Upon Blood, Muscle and Adipose Tissue Content and Function: Dosing and Washout Study
- ClinicalTrials.gov ID
- NCT04772040
- Acronym / sponsor ID
- 280280
- Conditions
- Aging, Sarcopenia, Muscle Atrophy
- Keywords
- Omega-3 polyunsaturated fatty acids, Fish oil supplementation, Washout, Dosing strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- Danone Nutricia Research
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled trial, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Young loading dose group | Experimental | Dietary Supplement: Fish oil supplementationParticipants (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. |
| Old loading dose group | Experimental | Dietary Supplement: Fish oil supplementationParticipants (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. |
| Young constant dose group | Experimental | Dietary Supplement: Fish oil supplementationParticipants (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. |
| Old constant dose group | Experimental | Dietary Supplement: Fish oil supplementationParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil supplementationFish oil capsules. | Dietary supplement | Old constant dose group, Old loading dose group, Young constant dose group, Young loading dose group |
Primary outcome
Red blood cell lipid composition
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.
Skeletal muscle lipid composition
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.
Adipose tissue lipid composition
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.
3 secondary outcomes
Skeletal muscle tissue biopsy muscle protein turnover markers
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Adipose tissue biopsy inflammation markers
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Red blood cell lipid mediator markers
Time frame: Baseline (0 weeks), 4 weeks, 12 weeks (post-intervention), 20 weeks (post wash-out)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil supplementation in people with Aging and Sarcopenia, run by University of Stirling at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell lipid composition (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.