Polyunsaturated Fatty Acids Supplementation and Blood Metabolome

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: The high PUFA diet group

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland
    • Recruiting
    • Poznan University of Life Sciences
    • Contact: Agata Chmurzynska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.
NO_INTERVENTION: Control group; The Control group will receive general nutritional recommendations based on Human Nutrition Recommendations for Polish Population.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Investigators: Principal Investigator: Agata Chmurzynska, PhD, Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: metabolomics, proteomics, PUFA, nutrition; healthy people aged 18-50
• Other Study ID Numbers: LKB 1249/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No