Metabolism DisorderEXODYANCT03386461
Effect of Exercise and Omega-3 on Metabolic Health in Elderly
A study testing Exercise training and omega 3 supplementation in people with Metabolism Disorder and Adiposity, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder, Adiposity, Inflammatory Response
- What is being tested?
- Exercise training and omega 3 supplementation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elderly women: age 60-80
- non-trained (without regular physical activity)
- BMI in the range of 25-30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly
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.
Read the 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
- Conditions
- Metabolism Disorder, Adiposity, Inflammatory Response
- Being tested
- Exercise training, omega 3 supplementation, placebo
- Keywords
- elderly, exercise training, adipose tissue, omega-3 polyunsaturated fatty acids, inflammation, diferentiation of preadipocytes
- Medical subject headings
- Metabolic Diseases, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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 supplementationDietary supplement
Also called Calanus oil
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.
placeboDietary supplement
Also called sunflower oil
Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Exercise training; Dietary 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). Receives: Behavioral: Exercise training; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adipose tissue inflammation
analysis of distribution of immune cells (flow cytometry analysis)
Measured: through study completion, an average of 1 year
Change in adipose tissue inflammatory signalling
analysis of pro-resolving mediators (UPLC-MS/MS methodology)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Change in insulin sensitivity
Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)
Measured: through study completion, an average of 1 year
Change in physical performance
Maximum graded exercise test on bicycle ergometer (Vo2max)
Measured: through study completion, an average of 1 year
Change in gene expression in adipose tissue
mRNA expression of metabolic and inflammatory genes in adipose tissue
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start5 Jan 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Siklova, Charles University, Czech Republic
- Investigators
- Michaela Siklova, PhD, Principal investigator, Third faculty of medicine, Charles University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386461
- Sponsor's protocol ID
- AZV 16-29182A
- Acronym
- EXODYA
- Status last verified
- Feb 2020
- First submitted
- 18 Dec 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32902644Brezinova 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.
PubMed 31740387
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly
- ClinicalTrials.gov ID
- NCT03386461
- Acronym / sponsor ID
- EXODYA / AZV 16-29182A
- Conditions
- Metabolism Disorder, Adiposity, Inflammatory Response
- Keywords
- elderly, exercise training, adipose tissue, omega-3 polyunsaturated fatty acids, inflammation, diferentiation of preadipocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
| Arm | Type | Receives |
|---|---|---|
| Exercise + Omega 3 supplementation | Experimental | Behavioral: Exercise training, Dietary Supplement: omega 3 supplementationSubjects 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). |
| Exercise + placebo | Placebo comparator | Behavioral: Exercise training, Dietary Supplement: placeboSubjects 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). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elderly women: age 60-80
- non-trained (without regular physical activity)
- BMI in the range of 25-30 kg/m2
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingCombined 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. | Behavioural | Exercise + Omega 3 supplementation, Exercise + placebo |
| omega 3 supplementationAlso: Calanus oilCapsules 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. | Dietary supplement | Exercise + Omega 3 supplementation |
| placeboAlso: sunflower oilCapsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal. | Dietary supplement | Exercise + placebo |
Primary outcome
Change in adipose tissue inflammation
Time frame: through study completion, an average of 1 year
analysis of distribution of immune cells (flow cytometry analysis)
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)
3 secondary outcomes
Change in insulin sensitivity
Time frame: through study completion, an average of 1 year
Change in physical performance
Time frame: through study completion, an average of 1 year
Change in gene expression in adipose tissue
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 32902644Cizkova 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.
- Derived from this study: PubMed 31740387Brezinova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Siklova, PhD principal investigator
Third faculty of medicine, Charles University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and omega 3 supplementation in people with Metabolism Disorder and Adiposity, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adipose tissue inflammation (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386461, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.