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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03059836
Other study ID # 1457
Secondary ID
Status Completed
Phase N/A
First received February 15, 2017
Last updated March 20, 2018
Start date February 28, 2017
Est. completion date February 28, 2018

Study information

Verified date March 2018
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
n3 PUFA-enriched fish oil
3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
Placebo
Organic Sunflower Oil 5000mg per day

Locations

Country Name City State
Canada Exercise Metabolism Research Laboratory, McMaster Univeristy Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
McMaster University University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Integrated Rates of Muscle Protein Synthesis Change in Muscle Protein Synthesis Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
Secondary Skeletal Muscle Strength Change in Skeletal Muscle Strength Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
Secondary Muscle Lipid Composition 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
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