Personalized Nutrition Caffeine Intake in Healthy Adults.

Not Applicable

Completed

• Conditions: CYP1A2 Polymorphism
• Interventions: Behavioral: Control group without genotype information; Behavioral: Intervention group with genotype information

• Registration Number: NCT04122053
• Lead Sponsor: Poznan University of Life Sciences

Brief 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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Primary Completion: 2021-02-17
• Study Completion: 2021-02-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group without genotype information	group will receive dietary advice
study group	Intervention group with genotype information	group will receive dietary advice and genotype information

Primary Outcome Measures

Name	Time	Method
Caffeine intake level from dietary sources	baseline, 20 week	caffeine intake (mg/day)
frequency of minor allel	Baseline	genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poznan University of Life Sciences; 🇵🇱 Poznań, Poland