- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465153
The Combined Effects of Resistance Training and Flax Oil Supplementation Upon Inflammation in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology, University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female greater than or equal to 60y
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Flax oil
|
14g alpha linolenic acid per day
Other Names:
Resistance training
|
|
PLACEBO_COMPARATOR: 2
corn oil
|
14g alpha linolenic acid per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Interleukin-6 and tumor necrosis factor-alpha at 12 weeks
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bench press and leg press strength, lean tissue mass, and muscle thickness of arm and leg flexors and extensors at 12 weeks
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Paus-Jenssen, M.D., University of Saskatchewan
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bio-REB 06-211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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