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

Early Phase 1

• Conditions: Obesity, Abdominal; Cardiovascular Risk Factor; Metabolic Syndrome
• Interventions: Dietary Supplement: Chia seeds supplementation (25 g); Dietary Supplement: Chia seeds supplementation (15 g); Dietary Supplement: Fish oil supplementation

• Registration Number: NCT04208308
• Lead Sponsor: Pavol Jozef Safarik University

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.

Study Timeline

• Study Start: 2013-01-15
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-20
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental negative group I	Chia seeds supplementation (25 g)	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
Experimental negative group II	Chia seeds supplementation (15 g)	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
Experimental negative group IV	Fish oil supplementation	Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)
Experimental positive group IV	Fish oil supplementation	Fish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)
Experimental positive group I	Chia seeds supplementation (25 g)	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
Experimental positive group II	Chia seeds supplementation (15 g)	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

Primary Outcome Measures

Name	Time	Method
glucose levels	6 months	fasting glucose in mmoL/L
Bile acids in serum	6 months	Concentration of serum bile acids (pg/mL)
Systemic inflammation activity	1 months	Interleukin 1 levels, interleukin 6 levels (pg/mL)
Body mass index	6 months	BMI kg/m2 6 months change.
Change in estrogen concentration	6 months	Assesment of concentration of estrogen (ng/mL)
Catalase activity	6 months	Determination of Catalase activity by electron microscopy
Antioxidant status	18 months	Determination of total antioxidant capacity (mmoL/L)
Superoxide dismutase activity	6 months	Determination of Superoxide dismutase activity by electron microscopy
Change in total cholesterol from baseline	6 months	percentual change in total cholesterol (mmoL/L) from baseline to 6months followup; - total genetic analysis, extracellular DNA
Tissue concentrations of nitric oxide	6months	Determination of nitric oxide synthetase activity by electron microscopy
NF kappa B activity	6 months	Determination of NF kappa B activity by electron microscopy

Trial Locations

Locations (1)

1st Department of Internal medicine, L. Pasteur University Hospital in Košice; 🇸🇰 Košice, Slovakia