n3 PUFA and Muscle-disuse Atrophy in Young Women
Primary Purpose
Muscle Atrophy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
n3 PUFA-enriched fish oil
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Atrophy focused on measuring n3 PUFA
Eligibility Criteria
Inclusion Criteria:
- Female
- Aged 18-30 years
Exclusion Criteria:
- 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
Sites / Locations
- Exercise Metabolism Research Laboratory, McMaster Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
n3 PUFA
Placebo
Arm Description
Intervention: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)
Intervention: Organic Sunflower Oil 5000mg per day
Outcomes
Primary Outcome Measures
Muscle Volume
Change in Muscle Volume Measured by Magnetic Resonance Imaging
Secondary Outcome Measures
Integrated Rates of Muscle Protein Synthesis
Change in Muscle Protein Synthesis
Skeletal Muscle Strength
Change in Skeletal Muscle Strength
Muscle Lipid Composition
Change in Muscle Lipid Composition
Full Information
NCT ID
NCT03059836
First Posted
February 15, 2017
Last Updated
March 20, 2018
Sponsor
McMaster University
Collaborators
University of Guelph
1. Study Identification
Unique Protocol Identification Number
NCT03059836
Brief Title
n3 PUFA and Muscle-disuse Atrophy in Young Women
Official Title
Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
University of Guelph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.
Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy
Keywords
n3 PUFA
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
n3 PUFA
Arm Type
Experimental
Arm Description
Intervention: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Organic Sunflower Oil 5000mg per day
Intervention Type
Dietary Supplement
Intervention Name(s)
n3 PUFA-enriched fish oil
Intervention Description
3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Organic Sunflower Oil 5000mg per day
Primary Outcome Measure Information:
Title
Muscle Volume
Description
Change in Muscle Volume Measured by Magnetic Resonance Imaging
Time Frame
Baseline (0 days), After (14 days) of unilateral limb immobilization and at 14 days post immobilization
Secondary Outcome Measure Information:
Title
Integrated Rates of Muscle Protein Synthesis
Description
Change in Muscle Protein Synthesis
Time Frame
Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
Title
Skeletal Muscle Strength
Description
Change in Skeletal Muscle Strength
Time Frame
Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
Title
Muscle Lipid Composition
Description
Change in Muscle Lipid Composition
Time Frame
Baseline (-28 days), and at Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Aged 18-30 years
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Phillips, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Metabolism Research Laboratory, McMaster Univeristy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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n3 PUFA and Muscle-disuse Atrophy in Young Women
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