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Clinical Trials/NCT03386461
NCT03386461CompletedNot Applicable

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

Charles University, Czech Republic1 site in 1 country55 target enrollmentStarted: January 5, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
Change in adipose tissue inflammatory signalling

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
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

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Exercise + Omega 3 supplementation

Experimental

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).

Intervention: Exercise training (Behavioral)

Exercise + Omega 3 supplementation

Experimental

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).

Intervention: omega 3 supplementation (Dietary Supplement)

Exercise + placebo

Placebo Comparator

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).

Intervention: Exercise training (Behavioral)

Exercise + placebo

Placebo Comparator

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).

Intervention: placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Change in adipose tissue inflammatory signalling

Time Frame: through study completion, an average of 1 year

analysis of pro-resolving mediators (UPLC-MS/MS methodology)

Change in adipose tissue inflammation

Time Frame: through study completion, an average of 1 year

analysis of distribution of immune cells (flow cytometry analysis)

Secondary Outcomes

  • Change in gene expression in adipose tissue(through study completion, an average of 1 year)
  • Change in insulin sensitivity(through study completion, an average of 1 year)
  • Change in physical performance(through study completion, an average of 1 year)

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michaela Siklova

Principal Investigator

Charles University, Czech Republic

Study Sites (1)

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