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Trial record 4 of 5 for:    calanus oil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386461
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Michaela Siklova, 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.

Condition or disease Intervention/treatment Phase
Metabolism Disorder Adiposity Inflammatory Response Behavioral: Exercise training Dietary Supplement: omega 3 supplementation Dietary Supplement: placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description: Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms
Primary Purpose: Basic Science
Official Title: Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise + 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).
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.
Other Name: Calanus oil

Placebo Comparator: Exercise + 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).
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: placebo
Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.
Other Name: sunflower oil




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386461


Locations
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Czechia
Third Faculty of Medicine, Charles University
Prague, Czechia, 100 00
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Michaela Siklova, PhD Third faculty of medicine, Charles University in Prague
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michaela Siklova, Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03386461    
Other Study ID Numbers: AZV 16-29182A
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michaela Siklova, Charles University, Czech Republic:
elderly
exercise training
adipose tissue
omega-3 polyunsaturated fatty acids
inflammation
diferentiation of preadipocytes
Additional relevant MeSH terms:
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Metabolic Diseases