NCT03059836

Brief Summary

This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in women undergoing 2 weeks of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

February 15, 2017

Last Update Submit

March 20, 2018

Conditions

Muscle Atrophy

Keywords

n3 PUFA

Outcome Measures

Primary Outcomes (1)

  • Muscle Volume

    Change in Muscle Volume Measured by Magnetic Resonance Imaging

    Baseline (0 days), After (14 days) of unilateral limb immobilization and at 14 days post immobilization

Secondary Outcomes (3)

  • Integrated Rates of Muscle Protein Synthesis

    Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization

  • Skeletal Muscle Strength

    Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization

  • Muscle Lipid Composition

    Baseline (-28 days), and at Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization

Study Arms (2)

n3 PUFA

EXPERIMENTAL

Intervention: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)

Dietary Supplement: n3 PUFA-enriched fish oil

Placebo

PLACEBO COMPARATOR

Intervention: Organic Sunflower Oil 5000mg per day

Dietary Supplement: Placebo

Interventions

n3 PUFA-enriched fish oilDIETARY_SUPPLEMENT

3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day

n3 PUFA
PlaceboDIETARY_SUPPLEMENT

Organic Sunflower Oil 5000mg per day

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Aged 18-30 years

You may not qualify if:

  • Take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded
  • A history of neuromuscular problems or muscle and/or bone wasting diseases
  • Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
  • Use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
  • Fish allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

February 28, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)