Inflammation Clinical Trial
Official title:
The Combined Effects of Resistance Training and Flax Oil Supplementation Upon Inflammation in Older Adults
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT05910489 -
Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect
|