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Clinical Trials/NCT04122053
NCT04122053
Completed
Not Applicable

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

Poznan University of Life Sciences1 site in 1 country94 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CYP1A2 Polymorphism
Sponsor
Poznan University of Life Sciences
Enrollment
94
Locations
1
Primary Endpoint
Caffeine intake level from dietary sources
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
February 17, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Poznan University of Life Sciences
Responsible Party
Principal Investigator
Principal Investigator

Agata Chmurzyńska

Professor

Poznan University of Life Sciences

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Dietary intake(Baseline)
  • body mass(BM)(Baseline, 20 weeks)
  • Blood LDL-cholesterol (LDL-C)(Baseline, 20 weeks)
  • Insulin (INS)(Baseline, 20 week)
  • hips circumference (HC)(Baseline, 20 weeks)
  • Fat Free Mass (FFM)(Baseline, 20 weeks)
  • Blood triacylglycerol (TAG)(Baseline, 20 weeks)
  • Total cholesterol (TChol)(Baseline, 20 weeks)
  • Blood HDL-cholesterol (HDL-C)(Baseline, 20 weeks)
  • Fat Mass% (FM%)(Baseline, 20 weeks)
  • Blood glucose (GLU)(Baseline, 20 weeks)
  • aspartate aminotransferase (ASPAT)(Baseline, 20 weeks)
  • Alanine transaminase (ALAT)(Baseline, 20 weeks)
  • waist circumference (WC)(Baseline, 20 weeks)

Study Sites (1)

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