n3 PUFA and Muscle-disuse Atrophy in Older Women

Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Older Women

This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia; Muscle Atrophy; Muscle Disuse Atrophy
• Intervention / Treatment: Dietary supplement: n3 PUFA-enriched fish oil; Dietary supplement: Placebo

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. More importantly, older adults (especially older women) that experience periods of muscle disuse are unable to recover muscle mass and strength. 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. A previous study from our group demonstrated that younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal muscle mass and strength during 2 weeks of immobilization. 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 in older women.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Exercise Metabolism Research Laboratory, McMaster Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Aged 55 - 75 years old
• non-smoking (for at least 2 years)
• > 5 years post-menopausal
• Body mass index (BMI) between 22 and 33 kg/m2
• Mini-Mental State Exam (MMSE) score > 20
• Acceptable medications include: Angiotensin Converting Enzyme (ACE), Beta-Blockers, Acetylsalicylic Acid, Calcium Channel blockers, Depression/Anxiety meds, Bisphosphonates (Fosamax®, Didrocal®, Actonel®, Aclasta®).

Exclusion Criteria:

• Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements.
• History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression over the past 2 years.
• Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral n-3 PUFA supplement ingestion and/or assessment of safety and study objectives
• Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
• Participation in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study
• Hypersensitivity to the test product
• Excessive alcohol consumption (>21 units/week)
• Prior gastrointestinal bypass surgery
• History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy
• Personal or family history of clotting disorder or deep vein thrombosis
• Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: n3 PUFA; n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)	Dietary supplement: n3 PUFA-enriched fish oil; 3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
PLACEBO_COMPARATOR: Placebo; Organic Sunflower Oil 5000mg per day	Dietary supplement: Placebo; Organic Sunflower Oil 5000mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Cross-Sectional Area	Changes in muscle cross-sectional area assessed by ultrasonography	Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrated rates of muscle protein synthesis	Change in muscle protein synthesis using doubly labelled water (D2O)	pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Skeletal muscle strength	Change in skeletal muscle strength using the Biodex Dynamometer	Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Endothelial function	Change in flow-mediated dilation	Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
Vascular function	Change in total femoral flow	Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ANTICIPATED): August 31, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: n3 PUFA
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Sarcopenia; Muscular Atrophy; Atrophy; Muscular Disorders, Atrophic
• Other Study ID Numbers: HiREB 1932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No