- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059836
n3 PUFA and Muscle-disuse Atrophy in Young Women
Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Young Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: n3 PUFA
Intervention: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)
|
3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
|
Placebo Comparator: Placebo
Intervention: Organic Sunflower Oil 5000mg per day
|
Organic Sunflower Oil 5000mg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Volume
Time Frame: Baseline (0 days), After (14 days) of unilateral limb immobilization and at 14 days post immobilization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Integrated Rates of Muscle Protein Synthesis
Time Frame: Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
|
Change in Muscle Protein Synthesis
|
Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
|
Skeletal Muscle Strength
Time Frame: Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
|
Change in Skeletal Muscle Strength
|
Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
|
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
|
Change in Muscle Lipid Composition
|
Baseline (-28 days), and at Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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