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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145453
Other study ID # UKB 872/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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