n3 PUFA and Muscle-disuse Atrophy in Young Women | NCT03059836

Studies
n3 PUFA and Muscle-disuse Atrophy in Young Women

NCT03059836

Sponsor

McMaster University

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Muscle Atrophy

Interventions

n3 PUFA-enriched fish oil
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Feb 15, 2017

First Submission Date that Met QC Criteria

Feb 16, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2018

Last Update Posted Date

Mar 22, 2018Actual

Name	Class
University of Guelph	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
n3 PUFA	Experimental	Intervention: 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	Intervention: Organic Sunflower Oil 5000mg per day	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
n3 PUFA-enriched fish oil	Dietary Supplement	3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day	n3 PUFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Skeletal Muscle Strength

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Self-representation of gender identity

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart M Phillips, PhD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Exercise Metabolism Research Laboratory, McMaster Univeristy		Hamilton	Ontario	L8S 4K1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009133	Muscular Atrophy

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy

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