Healthy LifestyleNCT04145453
Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
A study testing Intervention genotype personalized nutritional recommendations in people with Healthy Lifestyle and Taste Disorders, run by Poznan University of Life Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Taste Disorders, Diet Habit
- What is being tested?
- Intervention genotype personalized nutritional recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2019to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Lifestyle, Taste Disorders, Diet Habit
- Being tested
- Intervention genotype personalized nutritional recommendations, Control Group 1 personalized nutritional recommendations, Control Group 2 general nutritional recommendations
- Keywords
- TAS2R38 Polymorphism, bitter, taste, PAV, AVI, vegetables, personalized nutrition, genotype, intake, fruit and vegetables
- Medical subject headings
- Taste Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention genotype personalized nutritional recommendationsBehavioural
Also called with PAV haplotype
Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study
Control Group 1 personalized nutritional recommendationsBehavioural
Also called with PAV haplotype
Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study
Control Group 2 general nutritional recommendationsBehavioural
Also called with AVI haplotype
Participants will receive general nutritional recommendations to increase fruit and vegetables consumption
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control Group 2 general nutritional recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vegetables intake
Change in frequency of vegatables intake within the group and between the groups; Block vegetables intake screener
Measured: Baseline, 20 weeks
TAS2R38 polymorphism
genotyping of polymorphism TAS2R38 gene (rsr713598, rs1726866, and rs10246939)
Measured: baseline
Secondary outcomes (12)
Body Mass (BM)
change in body mass (kg) within the group and between the groups
Measured: Baseline, 20 weeks
Fat free mass (FFM)
change in FFM (kg) within the group and between the groups
Measured: Baseline, 20 weeks
Fat Mass (FM) %
change in Fat Mass % within the group and between the groups
Measured: Baseline, 20 weeks
Waist circumference (WC)
Change in WC (cm) within the group and between the groups
Measured: Baseline, 20 weeks
Total Cholesterol (TChol)
Changes in TChol (mg/dl) within the group and between the groups
Measured: Baseline, 20 weeks
LDL Cholesterol(LDL-Chol)
Changes in LDL-Chol (mg/dl) within the group and between the groups
Measured: Baseline, 20 weeks
HDL Cholesterol (HDL-Chol)
Changes in HDL-Chol (mg/dl) within the group and between the groups
Measured: Baseline, 20 weeks
Triglycerides (TG)
Changes in TG (mg/dl) within groups and between groups
Measured: Baseline, 20 week
Glucose (GLU)
Changes in GLU (mg/dl) within the group and between the groups
Measured: Baseline, 20 weeks
Insulin (INS)
Changes in INS (ulU/ml) within the group and between the groups
Measured: Baseline, 20 weeks
Alanine transaminase (ALAT)
Changes in ALAT (U/l) within the group and between the groups
Measured: Baseline, 20 weeks
aspartate aminotransferase (ASPAT)
Changes in ASPAT (U/l) within the group and between the groups
Measured: Baseline, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Oct 2019
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Bulczak, Msc, Principal investigator, Poznan University of Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145453
- Sponsor's protocol ID
- UKB 872/19
- Status last verified
- Jul 2022
- First submitted
- 3 Oct 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults
- ClinicalTrials.gov ID
- NCT04145453
- Acronym / sponsor ID
- UKB 872/19
- Conditions
- Healthy Lifestyle, Taste Disorders, Diet Habit
- Keywords
- TAS2R38 Polymorphism, bitter, taste, PAV, AVI, vegetables, personalized nutrition, genotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Intervention genotype personalized nutritional recommendationsParticipants 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. |
| control group 1 | Sham comparator | Behavioral: Control Group 1 personalized nutritional recommendationsParticipants 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. |
| Control group 2 | Active comparator | Behavioral: Control Group 2 general nutritional recommendationsParticipants with AVI haplotype will receive general recommendations regarding consumption of fruit and vegetables. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention genotype personalized nutritional recommendationsAlso: with PAV haplotypeParticipants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study | Behavioural | intervention group |
| Control Group 1 personalized nutritional recommendationsAlso: with PAV haplotypeParticipants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study | Behavioural | control group 1 |
| Control Group 2 general nutritional recommendationsAlso: with AVI haplotypeParticipants will receive general nutritional recommendations to increase fruit and vegetables consumption | Behavioural | Control group 2 |
Primary outcome
Vegetables intake
Time frame: Baseline, 20 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)
12 secondary outcomes
Body Mass (BM)
Time frame: Baseline, 20 weeks
Fat free mass (FFM)
Time frame: Baseline, 20 weeks
Fat Mass (FM) %
Time frame: Baseline, 20 weeks
Waist circumference (WC)
Time frame: Baseline, 20 weeks
Total Cholesterol (TChol)
Time frame: Baseline, 20 weeks
LDL Cholesterol(LDL-Chol)
Time frame: Baseline, 20 weeks
HDL Cholesterol (HDL-Chol)
Time frame: Baseline, 20 weeks
Triglycerides (TG)
Time frame: Baseline, 20 week
Glucose (GLU)
Time frame: Baseline, 20 weeks
Insulin (INS)
Time frame: Baseline, 20 weeks
Alanine transaminase (ALAT)
Time frame: Baseline, 20 weeks
aspartate aminotransferase (ASPAT)
Time frame: Baseline, 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Bulczak, Msc principal investigator
Poznan University of Life Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention genotype personalized nutritional recommendations in people with Healthy Lifestyle and Taste Disorders, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vegetables intake (time frame: Baseline, 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.