Effect of Exercise and Omega-3 on Metabolic Health in Elderly

Study Overview
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Brief Summary
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The aim of this project is to investigate in elderly women, the effect of combined aerobic and resistive training and concomitant supplementation with omega-3 fatty acids on adipogenesis, metabolic functions and pro-inflammatory status of adipose tissue and on systemic metabolic profile.

Detailed Description
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Aging is associated with development of disturbances of lipid and carbohydrate metabolism and with systemic pro-inflammatory state similarly to the alterations observed in obese individuals. Metabolic and immune dysfunction of adipose tissue has been suggested as an important contributing trigger to this condition. EXODYA project is a clinical study in elderly individuals that aims to establish benefits of lifestyle intervention and nutritional supplementation -either alone or in combination- for the amelioration of systemic and adipose tissue metabolic and immune disturbances. Effects of 4 months´ intervention with combined aerobic plus resistive exercise training and supplementation with omega-3 polyunsaturated fatty acids on systemic metabolic profile and molecular characteristics of adipose tissue will be investigated in elderly women. Thus, a proof-of-concept will be provided for novel recommendations and guidelines for lifestyle interventions in elderly population

Official Title
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Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly

Conditions
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Metabolism Disorder, Adiposity, Inflammatory Response

Intervention / Treatment
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* Behavioral: Exercise training
* Dietary Supplement: omega 3 supplementation
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elderly women: age 60-80 non-trained (without regular physical activity) BMI in the range of 25-30 kg/m2 Exclusion Criteria: diagnosed cancer, diabetes, liver and renal diseases, untreated hyper- or hypo-thyroidism, long term use of anti-inflammatory medication (anti-rheumatics and analgesics affecting cyclooxygenases (100 mg of anopyrin daily is acceptable), steroids and/or Omega-3 dietary supplements

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise + Omega 3 supplementation<br>Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly (Senior Fitness, and Faculty of Physical Education and Sport). Subjects will take 5 capsules od Calanus oil (containing approx. 250 mg EPA and DHA per day). | Behavioral: Exercise training<br>* Combined aerobic and resistive training 3 times a week for 4 months. The strength training will be performed at moderate intensity (i.e., 50-60% of RM), and moderate volume (i.e., 2 to 3 sets per exercise). Endurance training will be performed at moderate- to high-intensity (i.e., 60-85% of VO2max) in the form of continuous and interval training (for high intensities), respectively. The training intensity will be prescribed individually on the basis of the initial exercise testing. Subjects will be thoroughly instructed on effective home-based exercise and advised to exercise in total 5 days a week.<br>Dietary Supplement: omega 3 supplementation<br>* Capsules with high content of omega 3 fatty acids (Calanus oil) will be taken every day with lunch meal. The content of omega-3 fatty acids (EPA, DHA) per day should reach 250 mg.<br>* Other names: Calanus oil;|
| Placebo Comparator: Exercise + placebo<br>Subjects will be enrolled in physical activity program that consists of combined aerobic and resistive training 3 times a week for 4 months. Training will be supervised by physiotherapists experienced in exercise training of elderly. Subjects will take 5 capsules od placebo per day (provided by Calanus oil company, containing sunflower oil). | Behavioral: Exercise training<br>* Combined aerobic and resistive training 3 times a week for 4 months. The strength training will be performed at moderate intensity (i.e., 50-60% of RM), and moderate volume (i.e., 2 to 3 sets per exercise). Endurance training will be performed at moderate- to high-intensity (i.e., 60-85% of VO2max) in the form of continuous and interval training (for high intensities), respectively. The training intensity will be prescribed individually on the basis of the initial exercise testing. Subjects will be thoroughly instructed on effective home-based exercise and advised to exercise in total 5 days a week.<br>Dietary Supplement: placebo<br>* Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.<br>* Other names: sunflower oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adipose tissue inflammation | analysis of distribution of immune cells (flow cytometry analysis) | through study completion, an average of 1 year | 
| Change in adipose tissue inflammatory signalling | analysis of pro-resolving mediators (UPLC-MS/MS methodology) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity | Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate) | through study completion, an average of 1 year | 
| Change in physical performance | Maximum graded exercise test on bicycle ergometer (Vo2max) | through study completion, an average of 1 year | 
| Change in gene expression in adipose tissue | mRNA expression of metabolic and inflammatory genes in adipose tissue | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, exercise training, adipose tissue, omega-3 polyunsaturated fatty acids, inflammation, diferentiation of preadipocytes