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Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

Primary Purpose

Healthy Lifestyle, Taste Disorders, Diet Habit

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intervention genotype personalized nutritional recommendations
Control Group 1 personalized nutritional recommendations
Control Group 2 general nutritional recommendations
Sponsored by
Poznan University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Lifestyle focused on measuring TAS2R38 Polymorphism, bitter, taste, PAV, AVI, vegetables, personalized nutrition, genotype, intake, fruit and vegetables

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Poznan University of Life Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

intervention group

control group 1

Control group 2

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2019
Last Updated
July 7, 2022
Sponsor
Poznan University of Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04145453
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Lifestyle, Taste Disorders, Diet Habit
Keywords
TAS2R38 Polymorphism, bitter, taste, PAV, AVI, vegetables, personalized nutrition, genotype, intake, fruit and vegetables

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
lnvestigator is responsible for collecting the questionnaires and anonymizing the data
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group 1
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control group 2
Arm Type
Active Comparator
Arm Description
Participants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables.
Intervention Type
Behavioral
Intervention Name(s)
Intervention genotype personalized nutritional recommendations
Other Intervention Name(s)
with PAV haplotype
Intervention Description
Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study
Intervention Type
Behavioral
Intervention Name(s)
Control Group 1 personalized nutritional recommendations
Other Intervention Name(s)
with PAV haplotype
Intervention Description
Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study
Intervention Type
Behavioral
Intervention Name(s)
Control Group 2 general nutritional recommendations
Other Intervention Name(s)
with AVI haplotype
Intervention Description
Participants will receive general nutritional recommendations to increase fruit and vegetables consumption
Primary Outcome Measure Information:
Title
Vegetables intake
Description
Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
Time Frame
Baseline, 20 weeks
Title
TAS2R38 polymorphism
Description
genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Body Mass (BM)
Description
change in body mass (kg) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Fat free mass (FFM)
Description
change in FFM (kg) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Fat Mass (FM) %
Description
change in Fat Mass % within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Waist circumference (WC)
Description
Change in WC (cm) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Total Cholesterol (TChol)
Description
Changes in TChol (mg/dl) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
LDL Cholesterol(LDL-Chol)
Description
Changes in LDL-Chol (mg/dl) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
HDL Cholesterol (HDL-Chol)
Description
Changes in HDL-Chol (mg/dl) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Triglycerides (TG)
Description
Changes in TG (mg/dl) within groups and between groups
Time Frame
Baseline, 20 week
Title
Glucose (GLU)
Description
Changes in GLU (mg/dl) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Insulin (INS)
Description
Changes in INS (ulU/ml) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
Alanine transaminase (ALAT)
Description
Changes in ALAT (U/l) within the group and between the groups
Time Frame
Baseline, 20 weeks
Title
aspartate aminotransferase (ASPAT)
Description
Changes in ASPAT (U/l) within the group and between the groups
Time Frame
Baseline, 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Bulczak, Msc
Organizational Affiliation
Poznan University of Life Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznań
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

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