Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

Diet Habit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145453
• Other study ID #: UKB 872/19
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 17, 2022

Study information

• Verified date: July 2022
• Source: Poznan University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diet Habit
• Healthy Lifestyle
• Taste Disorders

Intervention

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
• 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
• Control Group 2 general nutritional recommendations
Participants will receive general nutritional recommendations to increase fruit and vegetables consumption

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vegetables intake	Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener	Baseline, 20 weeks
Primary	TAS2R38 polymorphism	genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)	baseline
Secondary	Body Mass (BM)	change in body mass (kg) within the group and between the groups	Baseline, 20 weeks
Secondary	Fat free mass (FFM)	change in FFM (kg) within the group and between the groups	Baseline, 20 weeks
Secondary	Fat Mass (FM) %	change in Fat Mass % within the group and between the groups	Baseline, 20 weeks
Secondary	Waist circumference (WC)	Change in WC (cm) within the group and between the groups	Baseline, 20 weeks
Secondary	Total Cholesterol (TChol)	Changes in TChol (mg/dl) within the group and between the groups	Baseline, 20 weeks
Secondary	LDL Cholesterol(LDL-Chol)	Changes in LDL-Chol (mg/dl) within the group and between the groups	Baseline, 20 weeks
Secondary	HDL Cholesterol (HDL-Chol)	Changes in HDL-Chol (mg/dl) within the group and between the groups	Baseline, 20 weeks
Secondary	Triglycerides (TG)	Changes in TG (mg/dl) within groups and between groups	Baseline, 20 week
Secondary	Glucose (GLU)	Changes in GLU (mg/dl) within the group and between the groups	Baseline, 20 weeks
Secondary	Insulin (INS)	Changes in INS (ulU/ml) within the group and between the groups	Baseline, 20 weeks
Secondary	Alanine transaminase (ALAT)	Changes in ALAT (U/l) within the group and between the groups	Baseline, 20 weeks
Secondary	aspartate aminotransferase (ASPAT)	Changes in ASPAT (U/l) within the group and between the groups	Baseline, 20 weeks