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

Inflammatory Response Clinical Trial

— EXODYA  

Official title:

Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386461
• Other study ID #: AZV 16-29182A
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Inflammatory Response
• Metabolic Diseases
• Metabolism Disorder

Intervention

Behavioral:
• 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.

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

Locations

Country	Name	City	State
Czechia	Third Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in adipose tissue inflammation	analysis of distribution of immune cells (flow cytometry analysis)	through study completion, an average of 1 year
Primary	Change in adipose tissue inflammatory signalling	analysis of pro-resolving mediators (UPLC-MS/MS methodology)	through study completion, an average of 1 year
Secondary	Change in insulin sensitivity	Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)	through study completion, an average of 1 year
Secondary	Change in physical performance	Maximum graded exercise test on bicycle ergometer (Vo2max)	through study completion, an average of 1 year
Secondary	Change in gene expression in adipose tissue	mRNA expression of metabolic and inflammatory genes in adipose tissue	through study completion, an average of 1 year