- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145453
Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poznań, Poland
- Poznan University of Life Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
Active Comparator: Control group 2
Participants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables.
|
Participants will receive general nutritional recommendations to increase fruit and vegetables consumption
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vegetables intake
Time Frame: Baseline, 20 weeks
|
Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
|
Baseline, 20 weeks
|
TAS2R38 polymorphism
Time Frame: baseline
|
genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass (BM)
Time Frame: Baseline, 20 weeks
|
change in body mass (kg) within the group and between the groups
|
Baseline, 20 weeks
|
Fat free mass (FFM)
Time Frame: Baseline, 20 weeks
|
change in FFM (kg) within the group and between the groups
|
Baseline, 20 weeks
|
Fat Mass (FM) %
Time Frame: Baseline, 20 weeks
|
change in Fat Mass % within the group and between the groups
|
Baseline, 20 weeks
|
Waist circumference (WC)
Time Frame: Baseline, 20 weeks
|
Change in WC (cm) within the group and between the groups
|
Baseline, 20 weeks
|
Total Cholesterol (TChol)
Time Frame: Baseline, 20 weeks
|
Changes in TChol (mg/dl) within the group and between the groups
|
Baseline, 20 weeks
|
LDL Cholesterol(LDL-Chol)
Time Frame: Baseline, 20 weeks
|
Changes in LDL-Chol (mg/dl) within the group and between the groups
|
Baseline, 20 weeks
|
HDL Cholesterol (HDL-Chol)
Time Frame: Baseline, 20 weeks
|
Changes in HDL-Chol (mg/dl) within the group and between the groups
|
Baseline, 20 weeks
|
Triglycerides (TG)
Time Frame: Baseline, 20 week
|
Changes in TG (mg/dl) within groups and between groups
|
Baseline, 20 week
|
Glucose (GLU)
Time Frame: Baseline, 20 weeks
|
Changes in GLU (mg/dl) within the group and between the groups
|
Baseline, 20 weeks
|
Insulin (INS)
Time Frame: Baseline, 20 weeks
|
Changes in INS (ulU/ml) within the group and between the groups
|
Baseline, 20 weeks
|
Alanine transaminase (ALAT)
Time Frame: Baseline, 20 weeks
|
Changes in ALAT (U/l) within the group and between the groups
|
Baseline, 20 weeks
|
aspartate aminotransferase (ASPAT)
Time Frame: Baseline, 20 weeks
|
Changes in ASPAT (U/l) within the group and between the groups
|
Baseline, 20 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ewa Bulczak, Msc, Poznan University of Life Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKB 872/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diet Habit
-
University of Rhode IslandCompletedDiet Modification | Diet HabitUnited States
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
NYU Langone HealthRecruitingDiet HabitUnited States
-
University of ReadingUniversity of PlymouthEnrolling by invitation
-
NYU Langone HealthNational Institute on Aging (NIA)Completed
-
The University of Tennessee, KnoxvilleCompleted
-
The University of Tennessee, KnoxvilleCompleted
-
University of California, DavisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
University of VictoriaCompleted
Clinical Trials on Intervention genotype personalized nutritional recommendations
-
Hospital General de MexicoUnknown
-
Instituto Nacional de Ciencias Medicas y Nutricion...Completed
-
Maimónides Biomedical Research Institute of CórdobaInstituto de Salud Carlos III; Hospital Universitario Reina Sofia de CordobaRecruiting
-
Hamilton Health Sciences CorporationSouthlake Regional Health Centre; Federal Economic Development Agency for Southern... and other collaboratorsCompletedHealth Behavior | Cardiovascular Risk Factor | Genetic InformationCanada
-
HaEmek Medical Center, IsraelCompleted
-
Chinese Academy of SciencesSir Run Run Shaw HospitalRecruitingHealthy | Obesity | Metabolism and Nutrition Disorder | HomeostasisChina
-
Galilee CBRUnknown
-
Sunnaas Rehabilitation HospitalUniversity of Oslo; University of CopenhagenRecruitingObesity | Spinal Cord Injuries | Metabolic DiseaseNorway
-
Fundació EurecatConsorci Sanitari del Maresme (CsdM); Centro de investigación biomédica en... and other collaboratorsRecruiting
-
Case Comprehensive Cancer CenterTerminatedAdenocarcinoma of Prostate | Adenocarcinoma of the Prostate Stage I | Adenocarcinoma of the Prostate Stage II | Adenocarcinoma of the Prostate Stage IIIUnited States