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n3 PUFA and Muscle-disuse Atrophy in Older Women

Primary Purpose

Muscle Atrophy, Muscle Disuse Atrophy, Sarcopenia

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

n3 PUFA-enriched fish oil

Placebo

About this trial

This is an interventional basic science trial for Muscle Atrophy focused on measuring n3 PUFA

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

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

n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)

Organic Sunflower Oil 5000mg per day

Outcomes

Primary Outcome Measures

Muscle Cross-Sectional Area

Changes in muscle cross-sectional area assessed by ultrasonography

Secondary Outcome Measures

Integrated rates of muscle protein synthesis

Change in muscle protein synthesis using doubly labelled water (D2O)

Skeletal muscle strength

Change in skeletal muscle strength using the Biodex Dynamometer

Endothelial function

Change in flow-mediated dilation

Vascular function

Change in total femoral flow

Full Information

NCT ID

NCT03808519

First Posted

January 14, 2019

Last Updated

February 12, 2020

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT03808519

Brief Title

n3 PUFA and Muscle-disuse Atrophy in Older Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 18, 2019 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Atrophy, Muscle Disuse Atrophy, Sarcopenia

Keywords

n3 PUFA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

n3 PUFA

Arm Type

Experimental

Arm Description

n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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 Cross-Sectional Area

Description

Changes in muscle cross-sectional area assessed by ultrasonography

Time Frame

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

Secondary Outcome Measure Information:

Title

Integrated rates of muscle protein synthesis

Description

Change in muscle protein synthesis using doubly labelled water (D2O)

Time Frame

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

Title

Skeletal muscle strength

Description

Change in skeletal muscle strength using the Biodex Dynamometer

Time Frame

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

Title

Endothelial function

Description

Change in flow-mediated dilation

Time Frame

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

Title

Vascular function

Description

Change in total femoral flow

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

self- representation of gender identity

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

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n3 PUFA and Muscle-disuse Atrophy in Older Women

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