- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05971147
Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation
Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation and Washout in Adult Women and Men
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chris McGlory, PhD
- Phone Number: 75410 6135336000
- Email: chris.mcglory@queensu.ca
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- Recruiting
- School of Kinesiology and Health Studies
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Contact:
- Chris McGlory, PhD
- Phone Number: 75410 6135336000
- Email: chris.mcglory@queensu.ca
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Contact:
- Sydney Smart, BSc
- Email: sydney.smart@queensu.ca
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Principal Investigator:
- Chris McGlory, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish Oil Group
All participants will be placed in this group
|
Participants in this group will receive 5g fish oil with high EPA and DHA content per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 0, 6, 8, 16, 20, and 22 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in erythrocyte EPA and DHA content
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
|
Erythrocyte phospholipid composition will be assessed at all time points by means of gas chromatography
|
0, 6, 8, 16, 20, and 22 weeks.
|
Changes in the expression of mitochondrial related proteins
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
|
Mitochondrial proteins involved in oxidative phosphorylation (e.g.
ANT1) will be assessed by means of western blotting at all time points.
|
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.
|
Translational factors involved in skeletal muscle protein synthesis (e.g.
p70S6K1) will be assessed by means of western blotting at all time points.
|
0, 6, 8, 16, 20, and 22 weeks.
|
Changes in circulating glucose concentrations
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
|
Glucose concentrations will be assessed by ELISA at all time points.
|
0, 6, 8, 16, 20, and 22 weeks.
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Changes in circulating insulin concentrations
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
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Insulin concentrations will be assessed by ELISA at all time points.
|
0, 6, 8, 16, 20, and 22 weeks.
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Changes in circulating TNFa concentrations
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
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TNFa concentrations will be assessed by ELISA at all time points.
|
0, 6, 8, 16, 20, and 22 weeks.
|
Changes in circulating CRP concentrations
Time Frame: 0, 6, 8, 16, 20, and 22 weeks.
|
CRP concentrations will be assessed by ELISA at all time points.
|
0, 6, 8, 16, 20, and 22 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6037330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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