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

Primary Purpose

Metabolism Disorder, Adiposity, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Exercise training
omega 3 supplementation
placebo
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolism Disorder focused on measuring elderly, exercise training, adipose tissue, omega-3 polyunsaturated fatty acids, inflammation, diferentiation of preadipocytes

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Third Faculty of Medicine, Charles University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise + Omega 3 supplementation

Exercise + placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in adipose tissue inflammation
analysis of distribution of immune cells (flow cytometry analysis)
Change in adipose tissue inflammatory signalling
analysis of pro-resolving mediators (UPLC-MS/MS methodology)

Secondary Outcome Measures

Change in insulin sensitivity
Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)
Change in physical performance
Maximum graded exercise test on bicycle ergometer (Vo2max)
Change in gene expression in adipose tissue
mRNA expression of metabolic and inflammatory genes in adipose tissue

Full Information

First Posted
December 18, 2017
Last Updated
February 13, 2020
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT03386461
Brief Title
Effect of Exercise and Omega-3 on Metabolic Health in Elderly
Acronym
EXODYA
Official Title
Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder, Adiposity, Inflammatory Response
Keywords
elderly, exercise training, adipose tissue, omega-3 polyunsaturated fatty acids, inflammation, diferentiation of preadipocytes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
Masking
ParticipantCare Provider
Masking Description
Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise + Omega 3 supplementation
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise + placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3 supplementation
Other Intervention Name(s)
Calanus oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
sunflower oil
Intervention Description
Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.
Primary Outcome Measure Information:
Title
Change in adipose tissue inflammation
Description
analysis of distribution of immune cells (flow cytometry analysis)
Time Frame
through study completion, an average of 1 year
Title
Change in adipose tissue inflammatory signalling
Description
analysis of pro-resolving mediators (UPLC-MS/MS methodology)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)
Time Frame
through study completion, an average of 1 year
Title
Change in physical performance
Description
Maximum graded exercise test on bicycle ergometer (Vo2max)
Time Frame
through study completion, an average of 1 year
Title
Change in gene expression in adipose tissue
Description
mRNA expression of metabolic and inflammatory genes in adipose tissue
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Siklova, PhD
Organizational Affiliation
Third faculty of medicine, Charles University in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Faculty of Medicine, Charles University
City
Prague
ZIP/Postal Code
100 00
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32902644
Citation
Cizkova T, Stepan M, Dadova K, Ondrujova B, Sontakova L, Krauzova E, Matous M, Koc M, Gojda J, Kracmerova J, Stich V, Rossmeislova L, Siklova M. Exercise Training Reduces Inflammation of Adipose Tissue in the Elderly: Cross-Sectional and Randomized Interventional Trial. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa630. doi: 10.1210/clinem/dgaa630.
Results Reference
derived
PubMed Identifier
31740387
Citation
Brezinova M, Cajka T, Oseeva M, Stepan M, Dadova K, Rossmeislova L, Matous M, Siklova M, Rossmeisl M, Kuda O. Exercise training induces insulin-sensitizing PAHSAs in adipose tissue of elderly women. Biochim Biophys Acta Mol Cell Biol Lipids. 2020 Feb;1865(2):158576. doi: 10.1016/j.bbalip.2019.158576. Epub 2019 Nov 16.
Results Reference
derived

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

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