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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for early_phase_1

Timeline

Completed

Started Jan 2013

Longer than P75 for early_phase_1

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.9 years study duration

Study Start

First participant enrolled

January 15, 2013

Completed

6.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed

2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed

Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

8.9 years

First QC Date

November 6, 2019

Last Update Submit

March 19, 2020

Conditions

Obesity, Abdominal Metabolic Syndrome Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (11)

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

Study Arms (10)

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

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

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

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)

Dietary Supplement: Fish oil supplementation

Control positive group

NO INTERVENTION

Without supplementation

Experimental positive group I

EXPERIMENTAL

Dietary Supplement: Chia seeds supplementation (25 g)

Experimental positive group II

EXPERIMENTAL

Dietary Supplement: Chia seeds supplementation (15 g)

Experimental positive group III

EXPERIMENTAL

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)

Dietary Supplement: Fish oil supplementation

Interventions

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

Experimental negative group IExperimental positive group I

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

Experimental negative group IIExperimental positive group II

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

Experimental negative group IIIExperimental positive group III

Fish oil supplementationDIETARY_SUPPLEMENT

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

Experimental negative group IVExperimental positive group IV

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

for obese participants were BMI≥29, age ≥18 and non-smokers, cardiovascular diseases. metabolic syndrome, obesity

You may not qualify if:

for all participants were cancer, inflammatory diseases, tuberculosis, renal and hepatic insufficiency, and pregnancy
for healthy participants without cardiovascular diseases, obesity and metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pavol Jozef Safarik Universitylead

Study Sites (1)

1st Department of Internal medicine, L. Pasteur University Hospital in Košice

Košice, 04011, Slovakia

RECRUITING

MeSH Terms

Conditions

Obesity, AbdominalMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

Zdenka Hertelyová, Dr., PhD.
Pavol Josef Šafarik University, Faculty of Medicine, 040 11 Košice, Slovakia
STUDY DIRECTOR

Central Study Contacts

Zdenka Hertelyová, Dr. PhD.

CONTACT

+421552343225 zdenka.hertelyova@upjs.sk

Alojz Bomba, MVDr., DrSc.

CONTACT

+421552343461 alojz.bomba@upjs.sk

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant professor

Study Record Dates

First Submitted

November 6, 2019

First Posted

December 23, 2019

Study Start

January 15, 2013

Primary Completion

December 15, 2021

Study Completion

December 20, 2021

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing: Will not share

Locations

SL(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Study Arms (10)

Control negative group

Experimental negative group I

Experimental negative group II

Experimental negative group III

Experimental negative group IV

Control positive group

Experimental positive group I

Experimental positive group II

Experimental positive group III

Experimental positive group IV

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations