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Completed

NCT Number: NCT04145453

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention genotype personalized nutritional recommendations

Behavioral

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

Control Group 1 personalized nutritional recommendations

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

Other names: with PAV haplotype

Control Group 2 general nutritional recommendations

Behavioral

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

Other names: with AVI haplotype

Primary outcomes

  1. Vegetables intake

    Time frame: Baseline, 20 weeks

    Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener

  2. TAS2R38 polymorphism

    Time frame: baseline

    genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)

Secondary outcomes

  1. Body Mass (BM)

    Time frame: Baseline, 20 weeks

    change in body mass (kg) within the group and between the groups

  2. Fat free mass (FFM)

    Time frame: Baseline, 20 weeks

    change in FFM (kg) within the group and between the groups

  3. Fat Mass (FM) %

    Time frame: Baseline, 20 weeks

    change in Fat Mass % within the group and between the groups

  4. Waist circumference (WC)

    Time frame: Baseline, 20 weeks

    Change in WC (cm) within the group and between the groups

  5. Total Cholesterol (TChol)

    Time frame: Baseline, 20 weeks

    Changes in TChol (mg/dl) within the group and between the groups

  6. LDL Cholesterol(LDL-Chol)

    Time frame: Baseline, 20 weeks

    Changes in LDL-Chol (mg/dl) within the group and between the groups

  7. HDL Cholesterol (HDL-Chol)

    Time frame: Baseline, 20 weeks

    Changes in HDL-Chol (mg/dl) within the group and between the groups

  8. Triglycerides (TG)

    Time frame: Baseline, 20 week

    Changes in TG (mg/dl) within groups and between groups

  9. Glucose (GLU)

    Time frame: Baseline, 20 weeks

    Changes in GLU (mg/dl) within the group and between the groups

  10. Insulin (INS)

    Time frame: Baseline, 20 weeks

    Changes in INS (ulU/ml) within the group and between the groups

  11. Alanine transaminase (ALAT)

    Time frame: Baseline, 20 weeks

    Changes in ALAT (U/l) within the group and between the groups

  12. aspartate aminotransferase (ASPAT)

    Time frame: Baseline, 20 weeks

    Changes in ASPAT (U/l) within the group and between the groups

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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