Personalized Nutrition Caffeine Intake in Healthy Adults.

NCT ID: NCT04122053

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-02-17

Brief Summary

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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

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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

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CYP1A2 Polymorphism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

group will receive dietary advice and genotype information

Group Type EXPERIMENTAL

Intervention group with genotype information

Intervention Type BEHAVIORAL

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

group will receive dietary advice

Group Type ACTIVE_COMPARATOR

Control group without genotype information

Intervention Type BEHAVIORAL

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.

Interventions

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Intervention group with genotype information

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.

Intervention Type BEHAVIORAL

Control group without genotype information

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 18-60
* daily coffee intake at a minimum 2 cups (or equivalent total caffeine intake)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Agata ChmurzyƄska

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewa Bulczak, Msc

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Life Science

Locations

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Poznan University of Life Sciences

Poznan, , Poland

Site Status

Countries

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Poland

Other Identifiers

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UKB196/19

Identifier Type: -

Identifier Source: org_study_id

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