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NCT Number: NCT03386461

Effect of Exercise and Omega-3 on Metabolic Health 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.

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Key information

Conditions

Metabolism Disorder Adiposity Body Weight Inflammation Inflammatory Response Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Third Faculty of Medicine, Charles University

Prague, 100 00, Czechia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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 supplementation

Dietary 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.

Other names: Calanus oil

Placebo

Dietary Supplement

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

Other names: sunflower oil

Primary outcomes

  1. Change in adipose tissue inflammation

    Time frame: through study completion, an average of 1 year

    analysis of distribution of immune cells (flow cytometry analysis)

  2. 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)

Secondary outcomes

  1. Change in insulin sensitivity

    Time frame: through study completion, an average of 1 year

    Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)

  2. Change in physical performance

    Time frame: through study completion, an average of 1 year

    Maximum graded exercise test on bicycle ergometer (Vo2max)

  3. Change in gene expression in adipose tissue

    Time frame: through study completion, an average of 1 year

    mRNA expression of metabolic and inflammatory genes in adipose tissue

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Acronym: EXODYA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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