Polyunsaturated Fatty Acids Supplementation and Blood Metabolome

NCT ID: NCT03892486

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-06-30

Brief Summary

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Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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The high PUFA diet group

This will receive detailed nutritional recommendations and will consume at least 4 table spoons of olive oil or 30 grams of nuts daily for 12 weeks.

Group Type EXPERIMENTAL

The high PUFA diet group

Intervention Type OTHER

Assumptions of nutritional intervention: in a randomized manner volunteers will be assigned to one of two groups: a control group which will receive general nutritional recommendations, based on the Polish nutrition pyramid, and the intervention group which will receive nutritional recommendations, based on the Polish nutrition pyramid and will consume at least 4 tablespoons of olive oil or 30 grams of nuts every day for 12 weeks.

Control group

The Control group will receive general nutritional recommendations based on Human Nutrition Recommendations for Polish Population.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The high PUFA diet group

Assumptions of nutritional intervention: in a randomized manner volunteers will be assigned to one of two groups: a control group which will receive general nutritional recommendations, based on the Polish nutrition pyramid, and the intervention group which will receive nutritional recommendations, based on the Polish nutrition pyramid and will consume at least 4 tablespoons of olive oil or 30 grams of nuts every day for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* good health,
* proper body weight
* not meeting the needs for polyunsaturated fatty acids

Exclusion Criteria

* increased body weight,
* limited communication to an extent that makes it impossible to carry out a food interview,
* eating disorders (according to food history),
* metabolic diseases,
* pregnancy,
* lactation,
* taking drugs that influence the metabolism of lipids or carbohydrates
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agata Chmurzynska, PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Life Sciences

Locations

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Poznan University of Life Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Joanna Ciborska, Ph.D

Role: CONTACT

+48 664 985 896

Agata Chmurzynska, Ph.D

Role: CONTACT

+ 48 61 846 61 81

Facility Contacts

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Agata Chmurzynska

Role: primary

Other Identifiers

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LKB 1249/19

Identifier Type: -

Identifier Source: org_study_id

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