Obesity, AbdominalEarly Phase 1CARDMET3NCT04208308
Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases (CARDMET3)
A Early Phase 1 study testing Chia seeds supplementation (25 g), Chia seeds supplementation (15 g) and Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20 in people with Obesity, Abdominal and Metabolic Syndrome, run by Pavol Jozef Safarik University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Metabolic Syndrome, Cardiovascular Risk Factor
- What is being tested?
- Chia seeds supplementation (25 g), Chia seeds supplementation (15 g) and Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Jan 2013to 20 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
1st Department of Internal medicine, L. Pasteur University Hospital in Košice
Košice, 04011
Martin Janicko, MD, PhD, +42155640 ext. 3515, interna1.snp@unlp.sk
About this study
Official title: Comparison of Effect of Animal and Plant Sources of Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases
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.
Read the 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.
- Being tested
- Chia seeds supplementation (25 g), Chia seeds supplementation (15 g), Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20, Fish oil supplementation
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chia seeds supplementation (25 g)Dietary supplement
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)Dietary supplement
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+20Dietary supplement
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 supplementationDietary supplement
TID
Daily dose:
Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)
| Study group | Role | What they receive |
|---|---|---|
| Control negative group | No intervention | Without supplementation |
| Experimental negative group I | Experimental | 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 Receives: Dietary Supplement: Chia seeds supplementation (25 g) |
| Experimental negative group II | Experimental | 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 Receives: Dietary Supplement: Chia seeds supplementation (15 g) |
| Experimental negative group III | Experimental | 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 Receives: Dietary Supplement: Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20 |
| Experimental negative group IV | Experimental | Fish oil supplementation
Daily dose:
Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg) Receives: Dietary Supplement: Fish oil supplementation |
| Control positive group | No intervention | Without supplementation |
| Experimental positive group I | Experimental | 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 Receives: Dietary Supplement: Chia seeds supplementation (25 g) |
| Experimental positive group II | Experimental | 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 Receives: Dietary Supplement: Chia seeds supplementation (15 g) |
| Experimental positive group III | Experimental | 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 Receives: Dietary Supplement: Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20 |
| Experimental positive group IV | Experimental | Fish oil supplementation
Daily dose:
Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg) Receives: Dietary Supplement: Fish oil supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
BMI kg/m2 6 months change.
Measured: 6 months
glucose levels
fasting glucose in mmoL/L
Measured: 6 months
Change in total cholesterol from baseline
percentual change in total cholesterol (mmoL/L) from baseline to 6months followup
- total genetic analysis, extracellular DNA
Measured: 6 months
Systemic inflammation activity
Interleukin 1 levels, interleukin 6 levels (pg/mL)
Measured: 1 months
Antioxidant status
Determination of total antioxidant capacity (mmoL/L)
Measured: 18 months
Change in estrogen concentration
Assesment of concentration of estrogen (ng/mL)
Measured: 6 months
Bile acids in serum
Concentration of serum bile acids (pg/mL)
Measured: 6 months
Tissue concentrations of nitric oxide
Determination of nitric oxide synthetase activity by electron microscopy
Measured: 6months
NF kappa B activity
Determination of NF kappa B activity by electron microscopy
Measured: 6 months
Catalase activity
Determination of Catalase activity by electron microscopy
Measured: 6 months
Superoxide dismutase activity
Determination of Superoxide dismutase activity by electron microscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Jan 2013
- Primary completion15 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy and obese people in different age categories.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Janičko, Pavol Jozef Safarik University
- Investigators
- Zdenka Hertelyová, Dr., PhD., Study director, Pavol Josef Šafarik University, Faculty of Medicine, 040 11 Košice, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208308
- Sponsor's protocol ID
- UEM001LFPJSU
- Acronym
- CARDMET3
- Status last verified
- Mar 2020
- First submitted
- 6 Nov 2019
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Animal and Plant Sources of Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases
- ClinicalTrials.gov ID
- NCT04208308
- Acronym / sponsor ID
- CARDMET3 / UEM001LFPJSU
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- Healthy and obese people in different age categories.
| Arm | Type | Receives |
|---|---|---|
| Control negative group | No intervention | –Without supplementation |
| Experimental negative group I | Experimental | Dietary Supplement: 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 | Experimental | Dietary Supplement: 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 III | Experimental | Dietary Supplement: Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20Combine 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 |
| Experimental negative group IV | Experimental | Dietary Supplement: Fish oil supplementationFish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg) |
| Control positive group | No intervention | –Without supplementation |
| Experimental positive group I | Experimental | Dietary Supplement: 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 | Experimental | Dietary Supplement: 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 positive group III | Experimental | Dietary Supplement: Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20Combine 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 |
| Experimental positive group IV | Experimental | Dietary Supplement: Fish oil supplementationFish oil supplementation Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- for all participants were cancer, inflammatory diseases, tuberculosis, renal and hepatic insufficiency, and pregnancy
- for healthy participants without cardiovascular diseases, obesity and metabolic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Experimental negative group I, Experimental positive group I |
| 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 | Experimental negative group II, Experimental positive group II |
| Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20Chia 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 | Experimental negative group III, Experimental positive group III |
| Fish oil supplementationTID Daily dose: Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg) | Dietary supplement | Experimental negative group IV, Experimental positive group IV |
Primary outcome
Body mass index
Time frame: 6 months
BMI kg/m2 6 months change.
glucose levels
Time frame: 6 months
fasting glucose in mmoL/L
Change in total cholesterol from baseline
Time frame: 6 months
percentual change in total cholesterol (mmoL/L) from baseline to 6months followup - total genetic analysis, extracellular DNA
Systemic inflammation activity
Time frame: 1 months
Interleukin 1 levels, interleukin 6 levels (pg/mL)
Antioxidant status
Time frame: 18 months
Determination of total antioxidant capacity (mmoL/L)
Change in estrogen concentration
Time frame: 6 months
Assesment of concentration of estrogen (ng/mL)
Bile acids in serum
Time frame: 6 months
Concentration of serum bile acids (pg/mL)
Tissue concentrations of nitric oxide
Time frame: 6months
Determination of nitric oxide synthetase activity by electron microscopy
NF kappa B activity
Time frame: 6 months
Determination of NF kappa B activity by electron microscopy
Catalase activity
Time frame: 6 months
Determination of Catalase activity by electron microscopy
Superoxide dismutase activity
Time frame: 6 months
Determination of Superoxide dismutase activity by electron microscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zdenka Hertelyová, Dr., PhD. study director
Pavol Josef Šafarik University, Faculty of Medicine, 040 11 Košice, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chia seeds supplementation (25 g), Chia seeds supplementation (15 g) and Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20 in people with Obesity, Abdominal and Metabolic Syndrome, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zdenka Hertelyová, Dr. PhD. (+421552343225, zdenka.hertelyova@upjs.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.