NCT05971147

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

July 18, 2023

Last Update Submit

January 27, 2025

Conditions

Keywords

Omega-3 fatty acidsEicosapentaenoic acidDocosahexaenoic acidFish oilSkeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Changes in skeletal muscle EPA and DHA content

    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 Outcomes (7)

  • Changes in the expression of mitochondrial related proteins

    0, 6, 8, 16, 20, and 22 weeks.

  • Changes in erythrocyte EPA and DHA content

    0, 6, 8, 16, 20, and 22 weeks.

  • Changes in the expression of translational factors related to skeletal muscle protein synthesis

    0, 6, 8, 16, 20, and 22 weeks.

  • Changes in circulating glucose concentrations

    0, 6, 8, 16, 20, and 22 weeks.

  • Changes in circulating insulin concentrations

    0, 6, 8, 16, 20, and 22 weeks.

  • +2 more secondary outcomes

Study Arms (1)

Fish Oil Group

EXPERIMENTAL

All participants will be placed in this group

Dietary Supplement: Fish oil

Interventions

Fish oilDIETARY_SUPPLEMENT

Participants in this group will receive 5g fish oil with high EPA and DHA content per day

Fish Oil Group

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Health Studies

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Chris McGlory, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All participants will take part in the same intervention, which will be fully disclosed to each participant.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single-arm 5g per day of omega-3 fatty acid intake (3750 mg EPA and 1250 mg DHA)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 2, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 13, 2025

Last Updated

January 29, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Data will be retained by the investigators, and shared under reasonable request.

Locations