Skeletal Muscle Fatty Acid MetabolismNCT05971147
Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation
A study testing Fish oil in people with Skeletal Muscle Fatty Acid Metabolism, run by Dr. Chris McGlory, PhD at 1 site in Canada.
Trial summary
Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to improved skeletal muscle strength and growth in women and men. However, what is unknown is if biological sex influences skeletal muscle phospholipid composition in response to omega-3 fatty acid supplementation. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Fatty Acid Metabolism
- What is being tested?
- Fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 13 Jan 2025
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 19-30 years
- BMI between 18-29 kg/m2
- Free of musculoskeletal injuries
- Participants not currently pregnant
- Participants willing to maintain current use of contraceptives or post-menopausal supplementation if any for the duration of the study.
- Not allergic to fish
- COVID-19 vaccinated to comply with Queen's University's return to campus guidelines, unless exempt by reasons from the Ontario Human Rights Code
- Recreationally active
Who cannot join
- Any muscular, neurological, respiratory or metabolic disease including diabetes
- Any form of cancer currently or in the last 5 years
- Currently taking fish oil supplements
- Currently taking any form of steroid
- Consuming >2 oily fish meals per week
- Pregnant
- Any current illness
- Any current/past lower limb injury/surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Kinesiology and Health Studies
Kingston, Ontario, K7L 3N6
About this study
Official title: Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation and Washout in Adult Women and Men
Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to improved skeletal muscle strength and growth in women and men. However, what is unknown is if biological sex influences skeletal muscle phospholipid composition in response to omega-3 fatty acid supplementation. Moreover, whilst time course changes in skeletal muscle phospholipid composition with omega-3 fatty acid intake have been established, no study has characterized a washout of omega-3 fatty acids from skeletal muscle phospholipids following cessation of omega-3 fatty acid intake. Thus, the aim of the present investigation is to establish a time course change and washout of omega-3 fatty acids from skeletal muscle phospholipids in response to omega-3 fatty acid intake. The investigators also aim to establish if this washout is impacted by biological sex.
Read the detailed description
Previous work has shown that supplementing with omega-3 fatty acids leads to increased omega-3 fatty acid composition of skeletal muscle phospholipids. This increase in skeletal muscle omega-3 fatty acid phospholipid composition following omega-3 fatty acid intake is linked to potentiated rates of skeletal muscle protein synthesis in response to amino acid and insulin infusion in older and younger women and men. Supplementation with omega-3 fatty acids is also known to enhance skeletal muscle strength and size in older adults. The exact biological mechanisms responsible for the anabolic influence of omega-3 fatty acid are unknown. However, there is emerging data that acid (EPA) and docosahexaenoic acid (DHA) play an active role. Indeed, there is now a growing body of evidence in cells, preclinical models, and humans that these key omega-3 fatty acids are primarily responsible for the observed anabolic impact of omega-3 fatty acids supplement intake towards skeletal muscle.
Whilst there is a growing body of literature supporting the anabolic potential of EPA and DHA in skeletal muscle, few studies have examined how biological sex influences EPA and DHA incorporation into skeletal muscle. Indeed, it has been purported that women EPA to DHA more efficiently in blood erythrocytes compared to men. To the investigators knowledge, no study examined how biological sex impacts changes in skeletal muscle phospholipid profiles in response to EPA and DHA intake. Moreover, no study has established a time course washout of EPA and DHA from skeletal muscle phospholipids in response to the cessation of EPA and DHA intake. The lack of data regarding EPA and DHA washout from skeletal muscle in response to EPA and DHA intake limits the ability to execute within subject cross over trials, which is important given that within-subject cross over trials possess more statistical power than parallel arm trials. Thus, establishing a washout of EPA and DHA from skeletal muscle phospholipids in response to EPA and DHA intake would provide important information for the design of future trials in this field.
- Conditions
- Skeletal Muscle Fatty Acid Metabolism
- Being tested
- Fish oil
- Keywords
- Omega-3 fatty acids, Eicosapentaenoic acid, Docosahexaenoic acid, Fish oil, Skeletal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Participants in this group will receive 5g fish oil with high EPA and DHA content per day
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil Group | Experimental | All participants will be placed in this group Receives: Dietary Supplement: Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skeletal muscle EPA and DHA content
Skeletal muscle phospholipid composition will be assessed at all time points by means of gas chromatography
Measured: At 0, 6, 8, 16, 20, and 22 weeks.
Secondary outcomes (7)
Changes in the expression of mitochondrial related proteins
Mitochondrial proteins involved in oxidative phosphorylation (e.g. ANT1) will be assessed by means of western blotting at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in erythrocyte EPA and DHA content
Erythrocyte phospholipid composition will be assessed at all time points by means of gas chromatography
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in the expression of translational factors related to skeletal muscle protein synthesis
Translational factors involved in skeletal muscle protein synthesis (e.g. p70S6K1) will be assessed by means of western blotting at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating glucose concentrations
Glucose concentrations will be assessed by ELISA at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating insulin concentrations
Insulin concentrations will be assessed by ELISA at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating TNFa concentrations
TNFa concentrations will be assessed by ELISA at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating CRP concentrations
CRP concentrations will be assessed by ELISA at all time points.
Measured: 0, 6, 8, 16, 20, and 22 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Fatty Acid MetabolismStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm 5g per day of omega-3 fatty acid intake (3750 mg EPA and 1250 mg DHA)
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Chris McGlory, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Chris McGlory, PhD, Queen's University
- Investigators
- Chris McGlory, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971147
- Sponsor's protocol ID
- 6037330
- Status last verified
- Jan 2024
- First submitted
- 18 Jul 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be retained by the investigators, and shared under reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation and Washout in Adult Women and Men
- ClinicalTrials.gov ID
- NCT05971147
- Acronym / sponsor ID
- 6037330
- Conditions
- Skeletal Muscle Fatty Acid Metabolism
- Keywords
- Omega-3 fatty acids, Eicosapentaenoic acid, Docosahexaenoic acid, Fish oil, Skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. Chris McGlory, PhDUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 2 Aug 2023 (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.
Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to improved skeletal muscle strength and growth in women and men. However, what is unknown is if biological sex influences skeletal muscle phospholipid composition in response to omega-3 fatty acid supplementation. Moreover, whilst time course changes in skeletal muscle phospholipid composition with omega-3 fatty acid intake have been established, no study has characterized a washout of omega-3 fatty acids from skeletal muscle phospholipids following cessation of omega-3 fatty acid intake. Thus, the aim of the present investigation is to establish a time course change and washout of omega-3 fatty acids from skeletal muscle phospholipids in response to omega-3 fatty acid intake. The investigators also aim to establish if this washout is impacted by biological sex.
Detailed description
Previous work has shown that supplementing with omega-3 fatty acids leads to increased omega-3 fatty acid composition of skeletal muscle phospholipids. This increase in skeletal muscle omega-3 fatty acid phospholipid composition following omega-3 fatty acid intake is linked to potentiated rates of skeletal muscle protein synthesis in response to amino acid and insulin infusion in older and younger women and men. Supplementation with omega-3 fatty acids is also known to enhance skeletal muscle strength and size in older adults. The exact biological mechanisms responsible for the anabolic influence of omega-3 fatty acid are unknown. However, there is emerging data that acid (EPA) and docosahexaenoic acid (DHA) play an active role. Indeed, there is now a growing body of evidence in cells, preclinical models, and humans that these key omega-3 fatty acids are primarily responsible for the observed anabolic impact of omega-3 fatty acids supplement intake towards skeletal muscle.
Whilst there is a growing body of literature supporting the anabolic potential of EPA and DHA in skeletal muscle, few studies have examined how biological sex influences EPA and DHA incorporation into skeletal muscle. Indeed, it has been purported that women EPA to DHA more efficiently in blood erythrocytes compared to men. To the investigators knowledge, no study examined how biological sex impacts changes in skeletal muscle phospholipid profiles in response to EPA and DHA intake. Moreover, no study has established a time course washout of EPA and DHA from skeletal muscle phospholipids in response to the cessation of EPA and DHA intake. The lack of data regarding EPA and DHA washout from skeletal muscle in response to EPA and DHA intake limits the ability to execute within subject cross over trials, which is important given that within-subject cross over trials possess more statistical power than parallel arm trials. Thus, establishing a washout of EPA and DHA from skeletal muscle phospholipids in response to EPA and DHA intake would provide important information for the design of future trials in this field.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm 5g per day of omega-3 fatty acid intake (3750 mg EPA and 1250 mg DHA)
| Arm | Type | Receives |
|---|---|---|
| Fish Oil Group | Experimental | Dietary Supplement: Fish oilAll participants will be placed in this group |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females 19-30 years
- BMI between 18-29 kg/m2
- Free of musculoskeletal injuries
- Participants not currently pregnant
- Participants willing to maintain current use of contraceptives or post-menopausal supplementation if any for the duration of the study.
Key exclusion criteria (8 listed)
- Any muscular, neurological, respiratory or metabolic disease including diabetes
- Any form of cancer currently or in the last 5 years
- Currently taking fish oil supplements
- Currently taking any form of steroid
- Consuming >2 oily fish meals per week
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 oilParticipants in this group will receive 5g fish oil with high EPA and DHA content per day | Dietary supplement | Fish Oil Group |
Primary outcome
Changes in skeletal muscle EPA and DHA content
Time frame: At 0, 6, 8, 16, 20, and 22 weeks.
Skeletal muscle phospholipid composition will be assessed at all time points by means of gas chromatography
7 secondary outcomes
Changes in the expression of mitochondrial related proteins
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in erythrocyte EPA and DHA content
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in the expression of translational factors related to skeletal muscle protein synthesis
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating glucose concentrations
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating insulin concentrations
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating TNFa concentrations
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
Changes in circulating CRP concentrations
Time frame: 0, 6, 8, 16, 20, and 22 weeks.
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 29 Jan 2025.
- Individual participant dataSharing planned: No. Data will be retained by the investigators, and shared under reasonable request.
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.
Chris McGlory, PhD principal investigator
Queen's University
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 in people with Skeletal Muscle Fatty Acid Metabolism, run by Dr. Chris McGlory, PhD at 1 site in Canada.
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 8 inclusion and 8 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 29 Jan 2025. 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 Canada. 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?
Changes in skeletal muscle EPA and DHA content (time frame: At 0, 6, 8, 16, 20, and 22 weeks.). 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 29 Jan 2025.