Personalized Nutrition Caffeine Intake in Healthy Adults.

Study Overview
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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.

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

Conditions
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CYP1A2 Polymorphism

Intervention / Treatment
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* Behavioral: Intervention group with genotype information
* Behavioral: Control group without genotype information


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>group will receive dietary advice and genotype information | Behavioral: Intervention group with genotype information<br>* 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.<br>|
| Active Comparator: Control group<br>group will receive dietary advice | Behavioral: Control group without genotype information<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caffeine intake level from dietary sources | caffeine intake (mg/day) | 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass(BM) | Changes in BM (kg) within groups and between groups | Baseline, 20 weeks | 
| Fat Free Mass (FFM) | FFM changes within (kg) groups and between groups | Baseline, 20 weeks | 
| Fat Mass% (FM%) | FM% changes within groups and between groups | Baseline, 20 weeks | 
| Total cholesterol (TChol) | Changes in TChol (mg/dl) within groups and between groups | Baseline, 20 weeks | 
| Blood HDL-cholesterol (HDL-C) | HDL-C (mg/dl) concentrations change within the group and between the groups | Baseline, 20 weeks | 
| Blood LDL-cholesterol (LDL-C) | LDL-C (mg/dl) concentrations change within the group and between the groups | Baseline, 20 weeks | 
| Blood triacylglycerol (TAG) | TAG (mg/dl) concentrations change within the group and between the groups | Baseline, 20 weeks | 
| Blood glucose (GLU) | GLU (mg/dl) concentrations change within the group and between the groups | Baseline, 20 weeks | 
| Insulin (INS) | INS (ulU/ml) concentrations change within the group and between the groups | Baseline, 20 week | 
| Dietary intake | macro and micronutrient intake (g,mg,ug) | Baseline | 
| aspartate aminotransferase (ASPAT) | ASPAT [U/l] Changes within groups and between groups | Baseline, 20 weeks | 
| Alanine transaminase (ALAT) | ALAT [U/l] Changes within groups and between groups | Baseline, 20 weeks | 
| waist circumference (WC) | WC (cm) Changes within groups and between groups | Baseline, 20 weeks | 
| hips circumference (HC) | HC (cm) changes within groups and between groups | Baseline, 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intake, caffeine, coffee, genotype, personalized nutrition