Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

NCT ID: NCT04145453

Last Updated: 2022-07-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-02-17

Brief Summary

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Personalized nutrition is one of the most up to date trends in human nutrition and gains much interest of general public and scientists as well. Although we have gained some knowledge on gene-trait associations, the real effectiveness and usefulness of genotype-based nutritional recommendations is unknown. Many personalized nutrition companies are on the market today, some of them use personalized nutrition based on genotype analysis. For this reason, scientific basis of this approach should be clarified.

Our project can thus increase knowledge which can be applied in dietary counseling practice. Although we focus on increase vegetable and fruits intake, the study is designed as a proof of concept.

Detailed Description

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In humans, the TAS2R38 receptor gene is responsible for differences in the perception of bitter taste. This gene codes for a G protein that is associated with a flavor receptor regulated by phenylthiocarbamide (PTC) and propylthiouracil (PROP) ligands, which by binding to the receptor determines the degree of bitter taste. Cruciferous vegetables contain glucosinolates and isothiocyanates, which resemble PTC and PROP and thereby affect their perception of bitter taste through the TAS2R38 regulated receptor.

The polymorphism of this gene allows to distinguish three phenotypes:

* insensitive to bitter taste \[bitter-non tasters\]
* moderately sensitive to bitter taste \[intermediate-bitter tasters\]
* sensitive to bitter taste \[bitter taster\] Previous studies have shown that people who are carriers of one PAV haplotype experience a bitter taste more than AVI / AVI homozygotes, which are less sensitive to bitter taste. Hence, the TAS2R38 gene polymorphism is associated with nutritional decisions, including choice of vegetables and coffee.

Aim of the study is to verify effectiveness of the genotype based dietary intervention in people with or without polymorphism of TAS2R38 gene.

Conditions

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Healthy Lifestyle Taste Disorders Diet Habit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To achieve the goals of the study, a group of healthy adults will be qualified. Genotype will be assed at the baseline. Consumption of fruit and vegetables will be assessed before and after intervention. The duration of the study will be 20 weeks. Blood results and body analyze will be assessed at the beginning and after the intervention. Overall food consumption will be assessed at the beginning. For the basic characteristics of study participants, their anthropometric and biochemical parameters will be analyzed twice at the baseline and after intervention. The intervention effect, including the TAS2R38 polymorphism, will be analyzed by statistical analysis.

In a randomized manner volunteers will be assigned to one of three groups: intervention and two control group.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
lnvestigator is responsible for collecting the questionnaires and anonymizing the data

Study Groups

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intervention group

Participants with PAV haplotype will receive personalised dietary recommendations regarding consumption of fruit and vegetables. The information about genotype will be given at the beginning of study.

Group Type EXPERIMENTAL

Intervention genotype personalized nutritional recommendations

Intervention Type BEHAVIORAL

Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study

control group 1

Participants with PAV haplotype will receive personalised dietary recommendations regarding consumption of fruit and vegetables, but the information about genotype will be given at the end of study.

Group Type SHAM_COMPARATOR

Control Group 1 personalized nutritional recommendations

Intervention Type BEHAVIORAL

Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study

Control group 2

Participants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables.

Group Type ACTIVE_COMPARATOR

Control Group 2 general nutritional recommendations

Intervention Type BEHAVIORAL

Participants will receive general nutritional recommendations to increase fruit and vegetables consumption

Interventions

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Intervention genotype personalized nutritional recommendations

Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study

Intervention Type BEHAVIORAL

Control Group 1 personalized nutritional recommendations

Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study

Intervention Type BEHAVIORAL

Control Group 2 general nutritional recommendations

Participants will receive general nutritional recommendations to increase fruit and vegetables consumption

Intervention Type BEHAVIORAL

Other Intervention Names

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with PAV haplotype with PAV haplotype with AVI haplotype

Eligibility Criteria

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Inclusion Criteria

* healthy

Exclusion Criteria

* injuries, chronic diseases (e.g. diabetes, metabolic syndrome, cancer, hyperthyroidism), recent diet, pregnancy, breastfeeding, limited communication to the extent that no nutritional history can be carried out, eating disorders (according to nutritional history)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Ewa Bulczak, Msc

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Life Science

Locations

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Poznan University of Life Sciences

Poznan, , Poland

Site Status

Countries

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Poland

Other Identifiers

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UKB 872/19

Identifier Type: -

Identifier Source: org_study_id

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