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

Pavol Jozef Safarik University

Status and phase: Unknown; Early Phase 1

Conditions: Obesity, Abdominal; Cardiovascular Risk Factor; Metabolic Syndrome

Treatments: Dietary Supplement: Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20; Dietary Supplement: Fish oil supplementation; Dietary Supplement: Chia seeds supplementation (25 g); Dietary Supplement: Chia seeds supplementation (15 g)

Study type: Interventional

Funder types: Other

Identifiers

NCT04208308

UEM001LFPJSU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 10 patient groups

Control negative group

No Intervention group

Description:

Without supplementation

Experimental negative group I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chia seeds supplementation (25 g)

Experimental negative group II

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chia seeds supplementation (15 g)

Experimental negative group III

Experimental group

Description:

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

Treatment:

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

Experimental negative group IV

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish oil supplementation

Control positive group

No Intervention group

Description:

Without supplementation

Experimental positive group I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chia seeds supplementation (25 g)

Experimental positive group II

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chia seeds supplementation (15 g)

Experimental positive group III

Experimental group

Description:

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

Treatment:

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

Experimental positive group IV

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish oil supplementation