Clinical trial NCT03386461: Effect of Exercise and Omega-3 on Metabolic Health in Elderly
Official title: Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism Disorder
Adiposity
Inflammatory Response
Keywords: elderly
exercise training
adipose tissue
omega-3 polyunsaturated fatty acids
inflammation
diferentiation of preadipocytes
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 55
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Change in adipose tissue inflammation
timeFrame: through study completion, an average of 1 year
measure: Change in adipose tissue inflammatory signalling
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Change in insulin sensitivity
timeFrame: through study completion, an average of 1 year
measure: Change in physical performance
timeFrame: through study completion, an average of 1 year
measure: Change in gene expression in adipose tissue
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Third Faculty of Medicine, Charles University
Study officials:
affiliation: Third faculty of medicine, Charles University in Prague
name: Michaela Siklova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.