n3 PUFA and Muscle-disuse Atrophy in Older Women

NCT03808519 | Terminated

• 1 other identifier: HiREB 1932
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Atrophy; Muscle Disuse Atrophy; Sarcopenia

Keywords

n3 PUFA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Integrated rates of muscle protein synthesis

  pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

• Skeletal muscle strength

  Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

• Endothelial function

  Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

• Vascular function

  Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)

Study Arms (2)

n3 PUFA

EXPERIMENTAL

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

Organic Sunflower Oil 5000mg per day

Dietary Supplement: Placebo

Interventions

n3 PUFA-enriched fish oil DIETARY_SUPPLEMENT

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

n3 PUFA

Placebo DIETARY_SUPPLEMENT

Organic Sunflower Oil 5000mg per day

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Gender Eligibility Details: self- representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®).

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscular Disorders, Atrophic; Sarcopenia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases

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: January 14, 2019
• First Posted: January 17, 2019
• Study Start: February 18, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)