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

NCT ID: NCT03386461

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2019-12-31

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

Conditions

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Metabolism Disorder Adiposity Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

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.

omega 3 supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

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).

Group Type PLACEBO_COMPARATOR

Exercise training

Intervention Type BEHAVIORAL

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.

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Calanus oil sunflower oil

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Michaela Siklova

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michaela Siklova, PhD

Role: PRINCIPAL_INVESTIGATOR

Third faculty of medicine, Charles University in Prague

Locations

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Third Faculty of Medicine, Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 32902644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31740387 (View on PubMed)

Other Identifiers

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AZV 16-29182A

Identifier Type: -

Identifier Source: org_study_id

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