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

Metabolic Syndrome Clinical Trial

— CARDMET3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208308
• Other study ID #: UEM001LFPJSU
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 15, 2013
• Est. completion date: December 20, 2021

Study information

• Verified date: March 2020
• Source: Pavol Jozef Safarik University
• Contact: Zdenka Hertelyová, Dr. PhD.
• Phone: +421552343225
• Email: zdenka.hertelyova[@]upjs.sk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 20, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Metabolic Diseases
• Metabolic Syndrome
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
Slovakia	1st Department of Internal medicine, L. Pasteur University Hospital in Košice	Košice

Sponsors (1)

Lead Sponsor	Collaborator
Pavol Jozef Safarik University

Country where clinical trial is conducted

Slovakia, 

Outcome

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