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Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

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ClinicalTrials.gov Identifier: NCT04145453
Recruitment Status : Not yet recruiting
First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Poznan University of Life Sciences

Tracking Information
First Submitted Date  ICMJE October 3, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date October 30, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Vegetables intake [ Time Frame: Baseline, 8 weeks ]
    Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
  • TAS2R38 polymorphism [ Time Frame: baseline ]
    genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Body Mass (BM) [ Time Frame: Baseline, 8 weeks ]
    change in body mass (kg) within the group and between the groups
  • Fat free mass (FFM) [ Time Frame: Baseline, 8 weeks ]
    change in FFM (kg) within the group and between the groups
  • Fat Mass (FM) % [ Time Frame: Baseline, 8 weeks ]
    change in Fat Mass % within the group and between the groups
  • Waist circumference (WC) [ Time Frame: Baseline, 8 weeks ]
    Change in WC (cm) within the group and between the groups
  • Total Cholesterol (TChol) [ Time Frame: Baseline, 8 weeks ]
    Changes in TChol (mg/dl) within the group and between the groups
  • LDL Cholesterol(LDL-Chol) [ Time Frame: Baseline, 8 weeks ]
    Changes in LDL-Chol (mg/dl) within the group and between the groups
  • HDL Cholesterol (HDL-Chol) [ Time Frame: Baseline, 8 weeks ]
    Changes in HDL-Chol (mg/dl) within the group and between the groups
  • Triglycerides (TG) [ Time Frame: Baseline, 8 week ]
    Changes in TG (mg/dl) within groups and between groups
  • Glucose (GLU) [ Time Frame: Baseline, 8 weeks ]
    Changes in GLU (mg/dl) within the group and between the groups
  • Insulin (INS) [ Time Frame: Baseline, 8 weeks ]
    Changes in INS (ulU/ml) within the group and between the groups
  • Alanine transaminase (ALAT) [ Time Frame: Baseline, 8 weeks ]
    Changes in ALAT (U/l) within the group and between the groups
  • aspartate aminotransferase (ASPAT) [ Time Frame: Baseline, 8 weeks ]
    Changes in ASPAT (U/l) within the group and between the groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Official Title  ICMJE Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Brief Summary The main goal of the project is to test whether the TAS2R38 polymorphism affects the effectiveness of dietary intervention aimed at increasing the consumption of vegetables and citrus fruits.
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 whether effectiveness of the dietary intervention depends on genotype.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:

To achieve the goals of the study, a group of healthy adults will be qualified. Potential participants will be assessed before and after consumption of fruit and vegetables. The duration of the study will be 8 weeks. Vegetable and fruit consumption, as well as overall food consumption, will be assessed at the beginning and after the intervention. For the basic characteristics of study participants, their anthropometric and biochemical parameters will be analyzed. The intervention effect, including the TAS2R38 polymorphism, will be analyzed by statistical analysis.

In a randomized manner volunteers will be assigned to one of two groups:intervention and study group.

Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy Lifestyle
  • Taste Disorders
  • Diet Habit
Intervention  ICMJE Behavioral: Intervention
Participants will receine general nutritional recommendations to increase fruit and vegetables consumption
Study Arms  ICMJE Experimental: intervention goup
will receive specific (genotype-based) dietary recommendations regarding the consumption of fruit and vegetables.
Intervention: Behavioral: Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Agata Chmurzyńska, Professor +48618487001 rektorat@up.poznan.pl
Contact: Ewa Bulczak, MSc 0048618466179 ewa.bulczak@up.poznan.pl
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04145453
Other Study ID Numbers  ICMJE UKB 872/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Poznan University of Life Sciences
Study Sponsor  ICMJE Poznan University of Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ewa Bulczak, Msc Poznan University of Life Science
PRS Account Poznan University of Life Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP