NCT03386461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

December 18, 2017

Last Update Submit

February 13, 2020

Conditions

Metabolism DisorderAdiposityInflammatory Response

Keywords

elderlyexercise trainingadipose tissueomega-3 polyunsaturated fatty acidsinflammationdiferentiation of preadipocytes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change in insulin sensitivity

    through study completion, an average of 1 year

  • Change in physical performance

    through study completion, an average of 1 year

  • Change in gene expression in adipose tissue

    through study completion, an average of 1 year

Study Arms (2)

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).

Behavioral: Exercise trainingDietary Supplement: omega 3 supplementation

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).

Behavioral: Exercise trainingDietary Supplement: placebo

Interventions

Exercise trainingBEHAVIORAL

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.

Exercise + Omega 3 supplementationExercise + placebo
omega 3 supplementationDIETARY_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.

Also known as: Calanus oil
Exercise + Omega 3 supplementation
placeboDIETARY_SUPPLEMENT

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

Also known as: sunflower oil
Exercise + placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elderly women: age 60-80
  • non-trained (without regular physical activity)
  • BMI in the range of 25-30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Faculty of Medicine, Charles University

Prague, 100 00, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 32902644DERIVED

  • 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.

    PMID: 31740387DERIVED

MeSH Terms

Conditions

Metabolic DiseasesObesityInflammation

Interventions

ExerciseSunflower Oil

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Michaela Siklova, PhD

    Third faculty of medicine, Charles University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 29, 2017

Study Start

January 5, 2017

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)