The ALA, DHA and EPA Esters in the Prevention of Cardiovascular Diseases.

NCT04743050 | Unknown Phase 3

• 1 other identifier: KB-596/2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Essential polyunsaturated fatty acids (EFAs) have a significant impact on human health, even before birth. Their supplementation is recommended at all ages, especially in people with cardiolovascular risks. The most valuable proven action of EFAs is the improvement of the lipid profile (including increase in HDL, the so-called "good cholesterol" and lowering LDL, the so-called "bad cholesterol"), preventing the development of atherosclerosis, strokes and heart attacks. We distinguish three fractions of EFAs: EPA, DHA and ALA. The best known are EPA and DHA, but in recent years the interest in ALA fraction has increased, as it is the only fraction that has pronounced anti-inflammatory properties, but also only ALA is not produced by the human body and must be supplied with food. We believe that the supplementation of the ALA fraction is as important as the supplementation of the well-known and recommended EPA and DHA fractions, moreover it also brings unique benefits. The aim of the study is to demonstrate the benefits of EFAs in the prevention of cardiovascular diseases in the group of adults. In the project, we also want to compare the benefits of supplementing various fractions. Each volunteer will be randomly assigned to one of 4 groups. Group No. 1 will be a group without the supplementation of essential fatty acids (EFAs), group No. 2 will receive supplementation with pure ALA fraction, group No. 3 will receive supplementation with EPA and DHA fractions, and group No. 4 will receive supplementation with all fractions, i.e. ALA, EPA and DHA. All persons from groups 1-4 will be examined three times: at the beginning, after three months and after six months (at the end of the project). The tests will include: blood pressure measurements, non-invasive measurements of body mass and composition, and laboratory tests: CRP, fasting glucose, lipid profile, and blood count. Both preparations for acid supplementation and tests are completely free for participants. Participation in the study is voluntary and is not associated with any health risk.

Conditions

Fatty Acids; Alpha-Linolenic Acid; Docosahexaenoic Acids; Eicosapentaenoic Acid; Preventive Health Services; Preventive Medicine; Cardiovascular Diseases; Anti-Inflammatory Agents

Keywords

Essential polyunsaturated fatty acids; EFA; EFAs; ALA; EPA; DHA; Esters

Outcome Measures

Primary Outcomes (6)

• Better glucose tolerance.

  Decrease/normalization in fasting glucose level.

  6 months

• Improvement in lipid metabolism.

  Decrease/normalization in lipid profile.

  6 months

• Lowering inflammatory markers.

  Decrease of inflammatory markers.

  6 months

• Lowering blood pressure.

  Decrease/normalization of blood pressure.

  6 months

• Improving blood count parameters

  Normalization of total blood count values.

  6 months

• Lowering body weight.

  Decrease of body weight, especially visceral adipose tissue.

  6 months

Study Arms (4)

Control Group

ACTIVE COMPARATOR

The control group will be a group without EFA supplementation.

Diagnostic Test: Diagnostic Tests

1st Experimental Group

EXPERIMENTAL

The first experimental group will receive supplementation with pure ALA fraction of EFA esters. 5 ml a day of OmegaRegen Original containing 2.9 g of ALA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests

2nd Experimental Group

EXPERIMENTAL

The second test group will receive supplementation of the EPA and DHA fraction of EFA esters. 5 ml a day of OmegaRegen EPA+DHA containing 0.032 g of EPA, 0.192 g of DHA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests

3rd Experimental Group

EXPERIMENTAL

The second test group will receive supplementation of the EPA and DHA fraction of EFA esters. 5 ml a day of OmegaRegen MAMA containing 2.9 g of ALA, 0.032 g of EPA, 0.192 g of DHA, 0.9 g of oleic acid and 0.8 g of linoleic acid for six months.

Drug: Fatty Acids, Unsaturated; Diagnostic Test: Diagnostic Tests

Interventions

Fatty Acids, Unsaturated DRUG

All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.

Also known as: OmegaRegen, Esters of Unsaturated Fatty Acids, EFA

1st Experimental Group; 2nd Experimental Group; 3rd Experimental Group

Diagnostic Tests DIAGNOSTIC_TEST

All participants will have laboratory tests marking: CRP, fasting glucose, lipid profile, total blood count, and additional tests, which will include blood pressure measurements and measurements of body mass and composition on a specialized body composition analyzer (InBody 270). All the mentioned tests will be performed at the time of joining the research program, after 3 months (in the middle of the research program) and after 6 months (at the end of the research program).

Also known as: Laboratory and Additional Tests

1st Experimental Group; 2nd Experimental Group; 3rd Experimental Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults of both sexes in good general condition.

You may not qualify if:

• pregnancy, acute diseases or uncontrolled / unchecked chronic diseases, indications for absolute treatment with lipid-lowering drugs or its modification, insulin-dependent diabetes mellitus, liver diseases, use of warfarin or heparin.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (3)

Department of Family Medicine at Wroclaw Medical University

Wroclaw, Dolny Slask, 51-141, Poland

Location

Model Practice of a Family Doctor Maria Bujnowska-Fedak

Wroclaw, Dolny Slask, 53-603, Poland

Location

TIGmed Private Medical Practice

Wroclaw, Dolny Slask, 53-603, Poland

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fatty Acids, Unsaturated; Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria M Bujnowska-Fedak, MD, PhD

  Departament of Family Medicine at Wroclaw Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: December 9, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: February 8, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)