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InflammationPhase 3NCT00465153

The Combined Effects of Resistance Training and Flax Oil Supplementation Upon Inflammation in Older Adults

A Phase 3 study testing flax oil containing alpha linolenic acid and Resistance exercise training in people with Inflammation and Sarcopenia, run by University of Saskatchewan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Inflammation, Sarcopenia
What is being tested?
flax oil containing alpha linolenic acid and Resistance exercise training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
Apr 2007to Aug 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female greater than or equal to 60y

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • College of Kinesiology, University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5B2

Other trials in Canada

About this study

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.

Read the detailed description

The specific aim is to determine the effect of progressive resistance training and α-linolenic acid supplementation for decreasing markers of inflammation and improving muscle mass and strength in older adults. This will be done by comparing older adults who will participate in the same resistance training program while supplementing their diet with either α-linolenic acid or placebo.

The hypotheses of this research are:

Resistance training combined with α-linolenic acid supplementation will decrease the pro-inflammatory cytokines interleukin-6 (IL-6) and tumour necrosis factor alpha (TNF-α), and increase strength and muscle mass more than resistance training and placebo supplementation in older individuals.

Sixty untrained males and females over 60 years of age will be recruited by newspaper ads. Subjects will be matched for sex and age and randomly assigned to supplement with 15 g/day α-linolenic acid (ALA) from flaxseed oil or placebo (corn oil) while participating in resistance training, 3 times per week for 12 weeks. The 15 g dose was chosen because it was effective for reducing pro-inflammatory cytokines in healthy adults over 4 weeks (Caughey et al., 1996). Twelve weeks of resistance training was chosen because it is effective for increasing muscle mass and strength in older adults (Chrusch et al., 2001). Our sample size of 30 subjects per group will be sufficient for detecting the expected changes in cytokines (Caughey et al., 1996) with a power of 80% and alpha level of 0.05. The primary dependent variables will be the pro-inflammatory cytokines IL-6 and TNF-α. Secondary dependent variables are chest press and leg press strength, lean tissue mass, and muscle thickness. A 2 (groups) x 2 (time, baseline and 12 weeks) ANOVA with repeated measures on the 2nd factor, will be used for analyses with alpha level of 0.05.

Methodology: Exercise Training: The exercise training will consist of a progressive resistance training program designed to increase skeletal muscle hypertrophy by having participants complete 12 different machine-based resistance exercises. The exercises will include: chest press, shoulder press, lat pulldown, bicep curl, triceps extension, leg press, knee flexion, knee extension, hip flexion/extension, and hip abduction/adduction. The subjects will complete between 3-4 sets of 6-12 repetitions at intensities between 65-80% of their 1 repetition maximum in a progressively overloaded fashion.

Biochemical Measures: Assessment of markers of inflammation will be done by biochemical blood analysis at baseline and after 12 weeks supplementation combined with resistance training. Blood will be drawn after an overnight night fast in the morning to account for changes due to diurnal variation. Approximately 10 mL of blood will be drawn from the antecubital vein of the arm. Serum will be assessed for the pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha using ELISA.

Fitness Testing: One repetition maximum (RM) strength tests will be done using chest press and leg press at baseline and 12 weeks. Subjects will complete a standardized warm-up of cycling and stretching before the strength test. The testing protocol will allow subjects to become familiar with the movement patterns of the resistance training machines before initiating the strength testing trials. Subjects will be gradually progressed to the maximal load that they can lift for the chest press and leg press. Once the subject is unable to complete a full repetition, the last successful attempt will be recorded as their 1RM.

Body Composition: Lean tissue and fat mass will be assessed by dual energy X-ray absorptiometry, and muscle thickness of the extensors and flexors of the elbows and knees will be determined by ultrasound at baseline and 12 weeks.

Being tested
flax oil containing alpha linolenic acid, Resistance exercise training
Keywords
Inflammation, cytokines, sarcopenia, strength, muscle, aging, exercise
Medical subject headings
Inflammation, Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • flax oil containing alpha linolenic acidDietary supplement

    Also called WN Pharmaceuticals

    14g alpha linolenic acid per day

  • Resistance exercise trainingBehavioural

    Resistance training

Study groups in NCT00465153
Study groupRoleWhat they receive
1ExperimentalFlax oil
Receives: Dietary Supplement: flax oil containing alpha linolenic acid; Behavioral: Resistance exercise training
2Placebo comparatorcorn oil
Receives: Dietary Supplement: flax oil containing alpha linolenic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interleukin-6 and tumor necrosis factor-alpha at 12 weeks

    Measured: 12 weeks

Secondary outcomes (1)
  1. Bench press and leg press strength, lean tissue mass, and muscle thickness of arm and leg flexors and extensors at 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00465153
Sponsor's protocol ID
Bio-REB 06-211
Status last verified
Nov 2007
First submitted
20 Apr 2007
Last updated
5 Nov 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing flax oil containing alpha linolenic acid and Resistance exercise training in people with Inflammation and Sarcopenia, run by University of Saskatchewan at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin-6 and tumor necrosis factor-alpha at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2007.

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