NCT00465153

Brief Summary

Loss of muscle mass and functional ability is a major concern for older individuals. Aging is associated with increased inflammation caused by release of hormone-like compounds termed "cytokines" which are involved in muscle protein degradation. Diets rich in ω-3 fatty acids decrease the production of pro-inflammatory cytokines, possibly by inhibiting production of lipids involved in cytokine synthesis. Our purpose is to assess the effect of dietary supplementation with an ω-3 fatty acid, α-linolenic acid (ALA) commonly found in flaxseed, combined with resistance training on pro-inflammatory cytokines, strength, and muscle mass in older adults. Progressive resistance training is considered to be the standard for increasing strength and muscle mass in older adults. We hypothesize that combining the two interventions will improve strength and muscle mass more than resistance training alone by modulating the inflammatory process associated with aging. Our proposed research will compare older individuals supplementing with ALA and placebo during a resistance training program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 5, 2007

Status Verified

November 1, 2007

First QC Date

April 20, 2007

Last Update Submit

November 1, 2007

Conditions

InflammationSarcopenia

Keywords

Inflammationcytokinessarcopeniastrengthmuscleagingexercise

Outcome Measures

Primary Outcomes (1)

  • Interleukin-6 and tumor necrosis factor-alpha at 12 weeks

    12 weeks

Secondary Outcomes (1)

  • Bench press and leg press strength, lean tissue mass, and muscle thickness of arm and leg flexors and extensors at 12 weeks

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Flax oil

Dietary Supplement: flax oil containing alpha linolenic acidBehavioral: Resistance exercise training

2

PLACEBO COMPARATOR

corn oil

Dietary Supplement: flax oil containing alpha linolenic acid

Interventions

flax oil containing alpha linolenic acidDIETARY_SUPPLEMENT

14g alpha linolenic acid per day

Also known as: WN Pharmaceuticals
12
Resistance exercise trainingBEHAVIORAL

Resistance training

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female greater than or equal to 60y

You may not qualify if:

  • allergies to flax or corn oil
  • Smokers
  • Consume more than 2 portions of oily fish per week
  • Take prescription or over the counter medication or natural health products that are anti-inflammatory in nature
  • Autoimmune or inflammatory disease
  • Susceptible to bowel irritation
  • Involved in resistance training equal to or greater than 1 time per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

InflammationSarcopeniaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip D Chilibeck, Ph.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Lisa Paus-Jenssen, M.D.

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2007

First Posted

April 24, 2007

Study Start

April 1, 2007

Study Completion

August 1, 2007

Last Updated

November 5, 2007

Record last verified: 2007-11

Locations

CA(1)