Polyunsaturated Fatty Acids Supplementation and Blood Metabolome

Study Overview
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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.

Official Title
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Analysis of the Effect of a Diet Enriched With Polyunsaturated Fatty Acids on the Proteomic and Metabolomic Profiles of Blood Plasma of Healthy People Aged 18-50

Conditions
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Healthy

Intervention / Treatment
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* Other: The high PUFA diet group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The high PUFA diet group<br>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. | Other: The high PUFA diet group<br>* 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.<br>|
| No Intervention: Control group<br>The Control group will receive general nutritional recommendations based on Human Nutrition Recommendations for Polish Population. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient intake | Nutrient intake (3-day food records) | 12 weeks | 
| Concentrations of lipoproteins and glucose | Serum concentrations of lipoproteins and glucose at baseline and after the intervention [mg/dl] | 12 weeks | 
| Proteomic analysis of plasma | The aim is to identify biomarkers in the blood and to determine the differences between people from the control and the intervention group | 12 weeks | 
| Metabolite concentrations in plasma | Metabolite concentrations in plasma samples are measured by high resolution mass spectrometry at baseline and after the intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass | body mass at baseline and after the intervention | 12 weeks | 
| Height | height | 12 weeks | 
| Percentage body fat | percentage body fat at baseline and after the intervention | 12 weeks | 
| Waist circumference | waist circumference at baseline and after the intervention | 12 weeks | 
| hip circumference | hip circumference at baseline and after the intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolomics, proteomics, PUFA, nutrition, healthy people aged 18-50