Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

July 7, 2022 updated by: Poznan University of Life Sciences

Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Poznań, Poland
        • Poznan University of Life Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study
Other Names:
  • with PAV haplotype
Sham Comparator: 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.
Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study
Other Names:
  • with PAV haplotype
Active Comparator: Control group 2
Participants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables.
Participants will receive general nutritional recommendations to increase fruit and vegetables consumption
Other Names:
  • with AVI haplotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vegetables intake
Time Frame: Baseline, 20 weeks
Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
Baseline, 20 weeks
TAS2R38 polymorphism
Time Frame: baseline
genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass (BM)
Time Frame: Baseline, 20 weeks
change in body mass (kg) within the group and between the groups
Baseline, 20 weeks
Fat free mass (FFM)
Time Frame: Baseline, 20 weeks
change in FFM (kg) within the group and between the groups
Baseline, 20 weeks
Fat Mass (FM) %
Time Frame: Baseline, 20 weeks
change in Fat Mass % within the group and between the groups
Baseline, 20 weeks
Waist circumference (WC)
Time Frame: Baseline, 20 weeks
Change in WC (cm) within the group and between the groups
Baseline, 20 weeks
Total Cholesterol (TChol)
Time Frame: Baseline, 20 weeks
Changes in TChol (mg/dl) within the group and between the groups
Baseline, 20 weeks
LDL Cholesterol(LDL-Chol)
Time Frame: Baseline, 20 weeks
Changes in LDL-Chol (mg/dl) within the group and between the groups
Baseline, 20 weeks
HDL Cholesterol (HDL-Chol)
Time Frame: Baseline, 20 weeks
Changes in HDL-Chol (mg/dl) within the group and between the groups
Baseline, 20 weeks
Triglycerides (TG)
Time Frame: Baseline, 20 week
Changes in TG (mg/dl) within groups and between groups
Baseline, 20 week
Glucose (GLU)
Time Frame: Baseline, 20 weeks
Changes in GLU (mg/dl) within the group and between the groups
Baseline, 20 weeks
Insulin (INS)
Time Frame: Baseline, 20 weeks
Changes in INS (ulU/ml) within the group and between the groups
Baseline, 20 weeks
Alanine transaminase (ALAT)
Time Frame: Baseline, 20 weeks
Changes in ALAT (U/l) within the group and between the groups
Baseline, 20 weeks
aspartate aminotransferase (ASPAT)
Time Frame: Baseline, 20 weeks
Changes in ASPAT (U/l) within the group and between the groups
Baseline, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ewa Bulczak, Msc, Poznan University of Life Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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