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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

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.

Condition or disease Intervention/treatment Phase
Healthy Lifestyle Taste Disorders Diet Habit Behavioral: Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention goup
will receive specific (genotype-based) dietary recommendations regarding the consumption of fruit and vegetables.
Behavioral: Intervention
Participants will receine general nutritional recommendations to increase fruit and vegetables consumption




Primary Outcome Measures :
  1. Vegetables intake [ Time Frame: Baseline, 8 weeks ]
    Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener

  2. TAS2R38 polymorphism [ Time Frame: baseline ]
    genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)


Secondary Outcome Measures :
  1. Body Mass (BM) [ Time Frame: Baseline, 8 weeks ]
    change in body mass (kg) within the group and between the groups

  2. Fat free mass (FFM) [ Time Frame: Baseline, 8 weeks ]
    change in FFM (kg) within the group and between the groups

  3. Fat Mass (FM) % [ Time Frame: Baseline, 8 weeks ]
    change in Fat Mass % within the group and between the groups

  4. Waist circumference (WC) [ Time Frame: Baseline, 8 weeks ]
    Change in WC (cm) within the group and between the groups

  5. Total Cholesterol (TChol) [ Time Frame: Baseline, 8 weeks ]
    Changes in TChol (mg/dl) within the group and between the groups

  6. LDL Cholesterol(LDL-Chol) [ Time Frame: Baseline, 8 weeks ]
    Changes in LDL-Chol (mg/dl) within the group and between the groups

  7. HDL Cholesterol (HDL-Chol) [ Time Frame: Baseline, 8 weeks ]
    Changes in HDL-Chol (mg/dl) within the group and between the groups

  8. Triglycerides (TG) [ Time Frame: Baseline, 8 week ]
    Changes in TG (mg/dl) within groups and between groups

  9. Glucose (GLU) [ Time Frame: Baseline, 8 weeks ]
    Changes in GLU (mg/dl) within the group and between the groups

  10. Insulin (INS) [ Time Frame: Baseline, 8 weeks ]
    Changes in INS (ulU/ml) within the group and between the groups

  11. Alanine transaminase (ALAT) [ Time Frame: Baseline, 8 weeks ]
    Changes in ALAT (U/l) within the group and between the groups

  12. aspartate aminotransferase (ASPAT) [ Time Frame: Baseline, 8 weeks ]
    Changes in ASPAT (U/l) within the group and between the groups



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145453


Contacts
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Contact: Agata Chmurzyńska, Professor +48618487001 rektorat@up.poznan.pl
Contact: Ewa Bulczak, MSc 0048618466179 ewa.bulczak@up.poznan.pl

Sponsors and Collaborators
Poznan University of Life Sciences
Investigators
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Principal Investigator: Ewa Bulczak, Msc Poznan University of Life Science

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Responsible Party: Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT04145453     History of Changes
Other Study ID Numbers: UKB 872/19
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poznan University of Life Sciences:
TAS2R38 Polymorphism
bitter
taste
PAV
AVI
vegetables
Additional relevant MeSH terms:
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Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms