Clinical trial NCT04145453: Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Official title: Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Taste Disorders
Diet Habit
Keywords: TAS2R38 Polymorphism
bitter
taste
PAV
AVI
vegetables
personalized nutrition
genotype
intake
fruit and vegetables
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Vegetables intake
timeFrame: Baseline, 20 weeks
measure: TAS2R38 polymorphism
timeFrame: baseline
Secondary outcomes:
measure: Body Mass (BM)
timeFrame: Baseline, 20 weeks
measure: Fat free mass (FFM)
timeFrame: Baseline, 20 weeks
measure: Fat Mass (FM) %
timeFrame: Baseline, 20 weeks
measure: Waist circumference (WC)
timeFrame: Baseline, 20 weeks
measure: Total Cholesterol (TChol)
timeFrame: Baseline, 20 weeks
measure: LDL Cholesterol(LDL-Chol)
timeFrame: Baseline, 20 weeks
measure: HDL Cholesterol (HDL-Chol)
timeFrame: Baseline, 20 weeks
measure: Triglycerides (TG)
timeFrame: Baseline, 20 week
measure: Glucose (GLU)
timeFrame: Baseline, 20 weeks
measure: Insulin (INS)
timeFrame: Baseline, 20 weeks
measure: Alanine transaminase (ALAT)
timeFrame: Baseline, 20 weeks
measure: aspartate aminotransferase (ASPAT)
timeFrame: Baseline, 20 weeks
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Science
name: Ewa Bulczak, Msc
role: PRINCIPAL_INVESTIGATOR
References: