NCT04208308

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pavol Jozef Safarik University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity, Abdominal
• Metabolic Syndrome
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chia seeds supplementation (25 g)	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
DIETARY_SUPPLEMENT	Chia seeds supplementation (15 g)	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
DIETARY_SUPPLEMENT	Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20	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
DIETARY_SUPPLEMENT	Fish oil supplementation	TID Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)

Timeline

• Start date: 2013-01-15
• Primary completion: 2021-12-15
• Completion: 2021-12-20
• First posted: 2019-12-23
• Last updated: 2020-03-20

Locations

1 site across 1 country: Slovakia