Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults

NCT04145453 | Completed

• 1 other identifier: UKB 872/19
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle; Taste Disorders; Diet Habit

Keywords

TAS2R38 Polymorphism; bitter; taste; PAV; AVI; vegetables; personalized nutrition; genotype; intake; fruit and vegetables

Outcome Measures

Primary Outcomes (2)

• Vegetables intake

  Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener

  Baseline, 20 weeks

• TAS2R38 polymorphism

  genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)

  baseline

Secondary Outcomes (12)

• Body Mass (BM)

  Baseline, 20 weeks

• Fat free mass (FFM)

  Baseline, 20 weeks

• Fat Mass (FM) %

  Baseline, 20 weeks

• Waist circumference (WC)

  Baseline, 20 weeks

• Total Cholesterol (TChol)

  Baseline, 20 weeks

Study Arms (3)

intervention group

EXPERIMENTAL

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.

Behavioral: Intervention genotype personalized nutritional recommendations

control group 1

SHAM COMPARATOR

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.

Behavioral: Control Group 1 personalized nutritional recommendations

Control group 2

ACTIVE COMPARATOR

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

Behavioral: Control Group 2 general nutritional recommendations

Interventions

Intervention genotype personalized nutritional recommendations BEHAVIORAL

Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study

Also known as: with PAV haplotype

intervention group

Control Group 1 personalized nutritional recommendations BEHAVIORAL

Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study

Also known as: with PAV haplotype

control group 1

Control Group 2 general nutritional recommendations BEHAVIORAL

Participants will receive general nutritional recommendations to increase fruit and vegetables consumption

Also known as: with AVI haplotype

Control group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, Poland

Location

MeSH Terms

Conditions

Taste Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Ewa Bulczak, Msc

  Poznan University of Life Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: lnvestigator is responsible for collecting the questionnaires and anonymizing the data
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 30, 2019
• Study Start: October 1, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)