Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT03386461
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2017-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise and Omega-3 on Metabolic Health in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Two types of pills (calanus or placebo) will be prescribed to subjects, investigator will randomly assign the subjects to the arms'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in adipose tissue inflammation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'analysis of distribution of immune cells (flow cytometry analysis)'}, {'measure': 'Change in adipose tissue inflammatory signalling', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'analysis of pro-resolving mediators (UPLC-MS/MS methodology)'}], 'secondaryOutcomes': [{'measure': 'Change in insulin sensitivity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Hyperinsulinemic izoglycemic clamp (GDR-glucose disposal rate)'}, {'measure': 'Change in physical performance', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Maximum graded exercise test on bicycle ergometer (Vo2max)'}, {'measure': 'Change in gene expression in adipose tissue', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mRNA expression of metabolic and inflammatory genes in adipose tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elderly', 'exercise training', 'adipose tissue', 'omega-3 polyunsaturated fatty acids', 'inflammation', 'diferentiation of preadipocytes'], 'conditions': ['Metabolism Disorder', 'Adiposity', 'Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '32902644', 'type': 'DERIVED', '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.'}, {'pmid': '31740387', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elderly women: age 60-80\n* non-trained (without regular physical activity)\n* BMI in the range of 25-30 kg/m2\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT03386461', 'acronym': 'EXODYA', 'briefTitle': 'Effect of Exercise and Omega-3 on Metabolic Health in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Effect of Exercise Training and Omega-3 Fatty Acids on Metabolic Health and Dysfunction of Adipose Tissue in Elderly', 'orgStudyIdInfo': {'id': 'AZV 16-29182A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise + Omega 3 supplementation', 'description': '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).', 'interventionNames': ['Behavioral: Exercise training', 'Dietary Supplement: omega 3 supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercise + placebo', 'description': '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).', 'interventionNames': ['Behavioral: Exercise training', 'Dietary Supplement: placebo']}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Exercise + Omega 3 supplementation', 'Exercise + placebo']}, {'name': 'omega 3 supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Calanus oil'], 'description': '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.', 'armGroupLabels': ['Exercise + Omega 3 supplementation']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['sunflower oil'], 'description': 'Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.', 'armGroupLabels': ['Exercise + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Third Faculty of Medicine, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Michaela Siklova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third faculty of medicine, Charles University in Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michaela Siklova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}