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

Not Applicable

Completed

• Conditions: Inflammatory Response; Metabolism Disorder; Adiposity
• Interventions: Behavioral: Exercise training; Dietary Supplement: placebo; Dietary Supplement: omega 3 supplementation

• Registration Number: NCT03386461
• Lead Sponsor: Charles University, Czech Republic

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

Study Timeline

• Study Start: 2017-01-05
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + placebo	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).
Exercise + Omega 3 supplementation	Exercise training	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).
Exercise + Omega 3 supplementation	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).
Exercise + placebo	Exercise training	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).

Primary Outcome Measures

Name	Time	Method
Change in adipose tissue inflammatory signalling	through study completion, an average of 1 year	analysis of pro-resolving mediators (UPLC-MS/MS methodology)
Change in adipose tissue inflammation	through study completion, an average of 1 year	analysis of distribution of immune cells (flow cytometry analysis)

Secondary Outcome Measures

Name	Time	Method
Change in gene expression in adipose tissue	through study completion, an average of 1 year	mRNA expression of metabolic and inflammatory genes in adipose tissue
Change in insulin sensitivity	through study completion, an average of 1 year	Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)
Change in physical performance	through study completion, an average of 1 year	Maximum graded exercise test on bicycle ergometer (Vo2max)

Trial Locations

Locations (1)

Third Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia