Clinical trial NCT04208308: Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases (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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity, Abdominal
Metabolic Syndrome
Cardiovascular Risk Factor
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy and obese people in different age categories.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body mass index
timeFrame: 6 months
measure: glucose levels
timeFrame: 6 months
measure: Change in total cholesterol from baseline
timeFrame: 6 months
measure: Systemic inflammation activity
timeFrame: 1 months
measure: Antioxidant status
timeFrame: 18 months
measure: Change in estrogen concentration
timeFrame: 6 months
measure: Bile acids in serum
timeFrame: 6 months
measure: Tissue concentrations of nitric oxide
timeFrame: 6months
measure: NF kappa B activity
timeFrame: 6 months
measure: Catalase activity
timeFrame: 6 months
measure: Superoxide dismutase activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Košice
country: Slovakia
facility: 1st Department of Internal medicine, L. Pasteur University Hospital in Košice
Study officials:
affiliation: Pavol Josef Šafarik University, Faculty of Medicine, 040 11 Košice, Slovakia
name: Zdenka Hertelyová, Dr., PhD.
role: STUDY_DIRECTOR
References: