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Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases (CARDMET3) (CARDMET3)

Primary Purpose

Obesity, Abdominal, Metabolic Syndrome, Cardiovascular Risk Factor

Status

Unknown status

Phase

Early Phase 1

Locations

Slovakia

Study Type

Interventional

Intervention

Chia seeds supplementation (25 g)

Chia seeds supplementation (15 g)

Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20

Fish oil supplementation

About this trial

This is an interventional prevention trial for Obesity, Abdominal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

for obese participants were BMI≥29, age ≥18 and non-smokers, cardiovascular diseases. metabolic syndrome, obesity
for healthy participants with normal weight, inclusion criteria BMI25, age ≥18, non-smokers

Exclusion Criteria:

for all participants were cancer, inflammatory diseases, tuberculosis, renal and hepatic insufficiency, and pregnancy
for healthy participants without cardiovascular diseases, obesity and metabolic syndrome

Sites / Locations

1st Department of Internal medicine, L. Pasteur University Hospital in KošiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Control negative group

Experimental negative group I

Experimental negative group II

Experimental negative group III

Experimental negative group IV

Control positive group

Experimental positive group I

Experimental positive group II

Experimental positive group III

Experimental positive group IV

Arm Description

Without supplementation

Chia seeds supplementation (25 g) On dose (25g) of chia seeds contains: energy 498,75 kJ / 118,75 kcal, protein 3,25 g, carbohydrates 9 g, fiber 6 g, fats 6,5 g, Calcium 160 mg Phosphorus 247,5 mg Kalium 37,5 mg Natrium 5,25 mg Zincum 0,975 mg Manganum 0,625 mg Omega-3 fatty acids 4,475 g Omega-6 fatty acids 1,475 g Vitamin B1 0,1 mg Vitamin B2 0,0075 mg Vitamin B3 0,75 mg Vitamin C 0,2 mg

Chia seeds supplementation (15 g) On dose (15g) of chia seeds contains: energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg

Combine supplementation: chia seeds and fish oil Daily dose: Chia seeds supplementation (15 g) and fish oil supplementation (pharmacological supplement) - Maxi Cor 70+20 (EPA 675 mg +DHA 510 mg) On dose (15g) of chia seeds contains: energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg

Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Without supplementation

Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Outcomes

Primary Outcome Measures

Body mass index

BMI kg/m2 6 months change.

glucose levels

fasting glucose in mmoL/L

Change in total cholesterol from baseline

percentual change in total cholesterol (mmoL/L) from baseline to 6months followup - total genetic analysis, extracellular DNA

Systemic inflammation activity

Interleukin 1 levels, interleukin 6 levels (pg/mL)

Antioxidant status

Determination of total antioxidant capacity (mmoL/L)

Change in estrogen concentration

Assesment of concentration of estrogen (ng/mL)

Bile acids in serum

Concentration of serum bile acids (pg/mL)

Tissue concentrations of nitric oxide

Determination of nitric oxide synthetase activity by electron microscopy

NF kappa B activity

Determination of NF kappa B activity by electron microscopy

Catalase activity

Determination of Catalase activity by electron microscopy

Superoxide dismutase activity

Determination of Superoxide dismutase activity by electron microscopy

Secondary Outcome Measures

Full Information

NCT ID

NCT04208308

First Posted

November 6, 2019

Last Updated

March 19, 2020

Sponsor

Pavol Jozef Safarik University

1. Study Identification

Unique Protocol Identification Number

NCT04208308

Brief Title

Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases (CARDMET3)

Acronym

CARDMET3

Official Title

Comparison of Effect of Animal and Plant Sources of Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2013 (Actual)

Primary Completion Date

December 15, 2021 (Anticipated)

Study Completion Date

December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pavol Jozef Safarik University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is aimed to assess the efficacy of animal, plant sources of omega-3 polyunsaturated fatty acids and omega-3 pharmacological supplements on obesity, metabolic syndrome and cardiovascular disease.

Detailed Description

More than four million people in Europe (47%) and more than 1.9 million people in European Union (EU) (40%) die of cardiovascular diseases (CVD) every year. CVD mortality in EU is 43% in women and 36% in men. In Central and Eastern Europe, much more people die of CVD than in Western, Northern and Southern European countries. The World Health Organization (WHO) states that number of deaths in Slovakia is much higher than in Western European countries, even higher than in V4 countries - Slovakia, Czech Republic, Poland and Hungary In the first stage of the project fatty acids will be analyzed with the focus on the ratio of omega-6 and omega-3 polyunsaturated fatty acids in fatty food for normal consumption and in nutritional supplements containing omega-3 polyunsaturated fatty acids. In the second phase of the project risk factors of cardiovascular diseases for people without and people with a history of cardiovascular disease will be monitored and compared. There will be monitored and compared a wide range of laboratory markers of clinical biochemistry, immunology, pathological physiology in order to determine cardiovascular risk for men and women in different age categories. The third stage will monitor the effect of natural plant and animal sources and pharmacological nutritional supplements with omega-3 polyunsaturated fatty acids on obesity, metabolic syndrome and cardiovascular risk factors. The aim of this study is to assess the efficacy of animal, plant sources of omega-3 polyunsaturated fatty acids and omega-3 pharmacological supplements on obesity, metabolic syndrome and cardiovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Abdominal, Metabolic Syndrome, Cardiovascular Risk Factor

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Healthy and obese people in different age categories.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control negative group

Arm Type

No Intervention

Arm Description

Without supplementation

Arm Title

Experimental negative group I

Arm Type

Experimental

Arm Description

Arm Title

Experimental negative group II

Arm Type

Experimental

Arm Description

Arm Title

Experimental negative group III

Arm Type

Experimental

Arm Description

Arm Title

Experimental negative group IV

Arm Type

Experimental

Arm Description

Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Arm Title

Control positive group

Arm Type

No Intervention

Arm Description

Without supplementation

Arm Title

Experimental positive group I

Arm Type

Experimental

Arm Description

Arm Title

Experimental positive group II

Arm Type

Experimental

Arm Description

Arm Title

Experimental positive group III

Arm Type

Experimental

Arm Description

Arm Title

Experimental positive group IV

Arm Type

Experimental

Arm Description

Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Intervention Type

Dietary Supplement

Intervention Name(s)

Chia seeds supplementation (25 g)

Intervention Description

Dosage: 1 daily dose energy 498,75 kJ / 118,75 kcal, protein 3,25 g, carbohydrates 9 g, fiber 6 g, fats 6,5 g, Calcium 160 mg Phosphorus 247,5 mg Kalium 37,5 mg Natrium 5,25 mg Zincum 0,975 mg Manganum 0,625 mg Omega-3 fatty acids 4,475 g Omega-6 fatty acids 1,475 g Vitamin B1 0,1 mg Vitamin B2 0,0075 mg Vitamin B3 0,75 mg Vitamin C 0,2 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Chia seeds supplementation (15 g)

Intervention Description

Dosage: 1 daily dose energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20

Intervention Description

Chia seeds - 1 daily dose Fish oil TID Chia seeds supplementation (15 g) and fish oil supplementation (pharmacological supplement) - Maxi Cor 70+20 (EPA 675 mg +DHA 510 mg) On dose (15g) of chia seeds contains: energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish oil supplementation

Intervention Description

TID Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Primary Outcome Measure Information:

Title

Body mass index

Description

BMI kg/m2 6 months change.

Time Frame

6 months

Title

glucose levels

Description

fasting glucose in mmoL/L

Time Frame

6 months

Title

Change in total cholesterol from baseline

Description

percentual change in total cholesterol (mmoL/L) from baseline to 6months followup - total genetic analysis, extracellular DNA

Time Frame

6 months

Title

Systemic inflammation activity

Description

Interleukin 1 levels, interleukin 6 levels (pg/mL)

Time Frame

1 months

Title

Antioxidant status

Description

Determination of total antioxidant capacity (mmoL/L)

Time Frame

18 months

Title

Change in estrogen concentration

Description

Assesment of concentration of estrogen (ng/mL)

Time Frame

6 months

Title

Bile acids in serum

Description

Concentration of serum bile acids (pg/mL)

Time Frame

6 months

Title

Tissue concentrations of nitric oxide

Description

Determination of nitric oxide synthetase activity by electron microscopy

Time Frame

6months

Title

NF kappa B activity

Description

Determination of NF kappa B activity by electron microscopy

Time Frame

6 months

Title

Catalase activity

Description

Determination of Catalase activity by electron microscopy

Time Frame

6 months

Title

Superoxide dismutase activity

Description

Determination of Superoxide dismutase activity by electron microscopy

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: for obese participants were BMI≥29, age ≥18 and non-smokers, cardiovascular diseases. metabolic syndrome, obesity for healthy participants with normal weight, inclusion criteria BMI25, age ≥18, non-smokers Exclusion Criteria: for all participants were cancer, inflammatory diseases, tuberculosis, renal and hepatic insufficiency, and pregnancy for healthy participants without cardiovascular diseases, obesity and metabolic syndrome

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zdenka Hertelyová, Dr. PhD.

Phone

+421552343225

zdenka.hertelyova@upjs.sk

First Name & Middle Initial & Last Name or Official Title & Degree

Alojz Bomba, MVDr., DrSc.

Phone

+421552343461

alojz.bomba@upjs.sk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zdenka Hertelyová, Dr., PhD.

Organizational Affiliation

Pavol Josef Šafarik University, Faculty of Medicine, 040 11 Košice, Slovakia

Official's Role

Study Director

Facility Information:

Facility Name

1st Department of Internal medicine, L. Pasteur University Hospital in Košice

City

Košice

ZIP/Postal Code

04011

Country

Slovakia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Janicko, MD, PhD

Phone

+42155640

Ext

3515

interna1.snp@unlp.sk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases (CARDMET3)

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