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

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Completed

CT.gov ID

NCT03386461

Collaborator

(none)

Enrollment

Location

Arms

35.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder Adiposity Inflammatory Response	Behavioral: Exercise training Dietary Supplement: omega 3 supplementation Dietary Supplement: placebo	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly womenThe exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women

Masking:

Double (Participant, Care Provider)

Masking Description:

Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 5, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise + Omega 3 supplementation 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 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. Dietary Supplement: omega 3 supplementation 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. Other Names: Calanus oil
Placebo Comparator: Exercise + placebo 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 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. Dietary Supplement: placebo Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal. Other Names: sunflower oil

Arm

Intervention/Treatment

Experimental: Exercise + Omega 3 supplementation

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

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.

Dietary Supplement: omega 3 supplementation

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.

Other Names:

Calanus oil

Placebo Comparator: Exercise + placebo

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

Dietary Supplement: placebo

Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.

Other Names:

sunflower oil

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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