CYP1A2 PolymorphismNCT04122053
Personalized Nutrition Caffeine Intake in Healthy Adults.
A study testing Intervention group with genotype information in people with CYP1A2 Polymorphism, 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
- CYP1A2 Polymorphism
- What is being tested?
- Intervention group with genotype information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2019to 17 Feb 2021
- 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
- age 18-60
- daily coffee intake at a minimum 2 cups (or equivalent total caffeine intake)
Who cannot join
- injuries,
- chronic diseases (e.g. diabetes, metabolic syndrome, cancer, hyperthyroidism),
- recent dieting,
- pregnancy or breastfeeding,
- no caffeine intake,
- taking chronic pain management pills which contain caffeine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Polymorphism of the CYP1A2 Gene and Caffeine Intake in 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. Moreover, the effect of using genotype information in dietary interventions aimed at decreasing caffeine intake has never been tested. Our project can thus increase knowledge which can be applied in dietary counseling practice. Although we focus on caffeine intake, the study is designed as a proof of concept.
Read the detailed description
Considering current knowledge and recognizing the existing gaps we hypothesize that providing genotype information may increase adherence to dietary recommendations.
The main aim of the project is thus testing the effectiveness of a genotype-based personalized dietary intervention targeted at decreasing caffeine intake.
Specific aims of the study include:
- Implementation of the application for mobile devices which will be designed to assess caffeine intake.
- Testing whether providing information on CYP1A2 polymorphism affects effectiveness of the dietary intervention aimed at decreasing caffeine intake.
- Testing whether changes in dietary behavior can persist over time To accomplish the study goals a group of healthy adults will be enrolled. Participants will complete an informed consent procedure. As we aim at decreasing caffeine intake, we plan to first screen for people drinking at least 2 cups of coffee or with total caffeine intake over 200 mg/day. Then genotype screening will be performed and eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information.
- Conditions
- CYP1A2 Polymorphism
- Being tested
- Intervention group with genotype information, Control group without genotype information
- Keywords
- intake, caffeine, coffee, genotype, personalized nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group with genotype informationBehavioural
Results of genotyping will be translated into personalised dietary recommendations. Subjects will be informed about their genotypes from the beginning of the study. The importance of personalised recommendations will be explained.
Control group without genotype informationBehavioural
Subjects will receive personalised dietary recommendations, but at the beginning they will not be informed about their genotypes and the meaning of personalisation. Information about their genotype will be given to the participants at the and of study.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | group will receive dietary advice and genotype information Receives: Behavioral: Intervention group with genotype information |
| Control group | Active comparator | group will receive dietary advice Receives: Behavioral: Control group without genotype information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caffeine intake level from dietary sources
caffeine intake (mg/day)
Measured: baseline, 20 week
frequency of minor allel
genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes
Measured: Baseline
Secondary outcomes (14)
body mass(BM)
Changes in BM (kg) within groups and between groups
Measured: Baseline, 20 weeks
Fat Free Mass (FFM)
FFM changes within (kg) groups and between groups
Measured: Baseline, 20 weeks
Fat Mass% (FM%)
FM% changes within groups and between groups
Measured: Baseline, 20 weeks
Total cholesterol (TChol)
Changes in TChol (mg/dl) within groups and between groups
Measured: Baseline, 20 weeks
Blood HDL-cholesterol (HDL-C)
HDL-C (mg/dl) concentrations change within the group and between the groups
Measured: Baseline, 20 weeks
Blood LDL-cholesterol (LDL-C)
LDL-C (mg/dl) concentrations change within the group and between the groups
Measured: Baseline, 20 weeks
Blood triacylglycerol (TAG)
TAG (mg/dl) concentrations change within the group and between the groups
Measured: Baseline, 20 weeks
Blood glucose (GLU)
GLU (mg/dl) concentrations change within the group and between the groups
Measured: Baseline, 20 weeks
Insulin (INS)
INS (ulU/ml) concentrations change within the group and between the groups
Measured: Baseline, 20 week
Dietary intake
macro and micronutrient intake (g,mg,ug)
Measured: Baseline
aspartate aminotransferase (ASPAT)
ASPAT [U/l] Changes within groups and between groups
Measured: Baseline, 20 weeks
Alanine transaminase (ALAT)
ALAT [U/l] Changes within groups and between groups
Measured: Baseline, 20 weeks
waist circumference (WC)
WC (cm) Changes within groups and between groups
Measured: Baseline, 20 weeks
hips circumference (HC)
HC (cm) changes within groups and between 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 posted10 Oct 2019
- Study start1 Oct 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CYP1A2 PolymorphismStudies 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
- eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agata Chmurzyńska, Poznan University of Life Sciences
- Investigators
- Ewa Bulczak, Msc, Principal investigator, Poznan University of Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122053
- Sponsor's protocol ID
- UKB196/19
- Status last verified
- Feb 2022
- First submitted
- 3 Oct 2019
- Last updated
- 18 Feb 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 18 Feb 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? Polymorphism of the CYP1A2 Gene and Caffeine Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT04122053
- Acronym / sponsor ID
- UKB196/19
- Conditions
- CYP1A2 Polymorphism
- Keywords
- intake, caffeine, coffee, genotype, personalized nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 10 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. Moreover, the effect of using genotype information in dietary interventions aimed at decreasing caffeine intake has never been tested. Our project can thus increase knowledge which can be applied in dietary counseling practice. Although we focus on caffeine intake, the study is designed as a proof of concept.
Detailed description
Considering current knowledge and recognizing the existing gaps we hypothesize that providing genotype information may increase adherence to dietary recommendations.
The main aim of the project is thus testing the effectiveness of a genotype-based personalized dietary intervention targeted at decreasing caffeine intake.
Specific aims of the study include:
- Implementation of the application for mobile devices which will be designed to assess caffeine intake.
- Testing whether providing information on CYP1A2 polymorphism affects effectiveness of the dietary intervention aimed at decreasing caffeine intake.
- Testing whether changes in dietary behavior can persist over time To accomplish the study goals a group of healthy adults will be enrolled. Participants will complete an informed consent procedure. As we aim at decreasing caffeine intake, we plan to first screen for people drinking at least 2 cups of coffee or with total caffeine intake over 200 mg/day. Then genotype screening will be performed and eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: Intervention group with genotype informationgroup will receive dietary advice and genotype information |
| Control group | Active comparator | Behavioral: Control group without genotype informationgroup will receive dietary advice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-60
- daily coffee intake at a minimum 2 cups (or equivalent total caffeine intake)
Key exclusion criteria (6 listed)
- injuries,
- chronic diseases (e.g. diabetes, metabolic syndrome, cancer, hyperthyroidism),
- recent dieting,
- pregnancy or breastfeeding,
- no caffeine intake,
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 group with genotype informationResults of genotyping will be translated into personalised dietary recommendations. Subjects will be informed about their genotypes from the beginning of the study. The importance of personalised recommendations will be explained. | Behavioural | study group |
| Control group without genotype informationSubjects will receive personalised dietary recommendations, but at the beginning they will not be informed about their genotypes and the meaning of personalisation. Information about their genotype will be given to the participants at the and of study. | Behavioural | Control group |
Primary outcome
Caffeine intake level from dietary sources
Time frame: baseline, 20 week
caffeine intake (mg/day)
frequency of minor allel
Time frame: Baseline
genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes
14 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
Total cholesterol (TChol)
Time frame: Baseline, 20 weeks
Blood HDL-cholesterol (HDL-C)
Time frame: Baseline, 20 weeks
Blood LDL-cholesterol (LDL-C)
Time frame: Baseline, 20 weeks
Blood triacylglycerol (TAG)
Time frame: Baseline, 20 weeks
Blood glucose (GLU)
Time frame: Baseline, 20 weeks
Insulin (INS)
Time frame: Baseline, 20 week
Dietary intake
Time frame: Baseline
aspartate aminotransferase (ASPAT)
Time frame: Baseline, 20 weeks
Alanine transaminase (ALAT)
Time frame: Baseline, 20 weeks
waist circumference (WC)
Time frame: Baseline, 20 weeks
hips circumference (HC)
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 18 Feb 2022.
- Individual participant dataSharing planned: No
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 group with genotype information in people with CYP1A2 Polymorphism, 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 2 inclusion and 6 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 18 Feb 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. 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?
Caffeine intake level from dietary sources (time frame: baseline, 20 week). 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 18 Feb 2022.