Clinical Trials Directory

Trials / Completed

CompletedNCT04122053

Personalized Nutrition Caffeine Intake in Healthy Adults.

Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Polymorphism of the CYP1A2 Gene and Caffeine Intake in Healthy Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
94 (actual)
Sponsor
Poznan University of Life Sciences · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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. 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntervention 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.
BEHAVIORALControl 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.

Timeline

Start date
2019-10-01
Primary completion
2021-02-17
Completion
2021-02-17
First posted
2019-10-10
Last updated
2022-02-18

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04122053. Inclusion in this directory is not an endorsement.