Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

Sponsor

Poznan University of Life Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04145453

Collaborator

(none)

174

Enrollment

Location

Arms

28.6

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Lifestyle Taste Disorders Diet Habit	Behavioral: Intervention genotype personalized nutritional recommendations Behavioral: Control Group 1 personalized nutritional recommendations Behavioral: Control Group 2 general nutritional recommendations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Investigator)

Masking Description:

lnvestigator is responsible for collecting the questionnaires and anonymizing the data

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Feb 17, 2022

Actual Study Completion Date :

Feb 17, 2022

Arms and Interventions

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.	Behavioral: 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 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.	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 Other Names: with PAV haplotype
Active Comparator: Control group 2 Participants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables.	Behavioral: Control Group 2 general nutritional recommendations Participants will receive general nutritional recommendations to increase fruit and vegetables consumption Other Names: with AVI haplotype

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.

Behavioral: 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

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.

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

Other Names:

with PAV haplotype

Active Comparator: Control group 2

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

Behavioral: Control Group 2 general nutritional recommendations

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

Other Names:

with AVI haplotype

Outcome Measures

Primary Outcome Measures

Vegetables intake [Baseline, 20 weeks]
Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
TAS2R38 polymorphism [baseline]
genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)