Clinical trial NCT04122053: Personalized Nutrition Caffeine Intake in Healthy Adults.
Official title: Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Polymorphism of the CYP1A2 Gene and Caffeine Intake in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CYP1A2 Polymorphism
Keywords: intake
caffeine
coffee
genotype
personalized nutrition
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caffeine intake level from dietary sources
timeFrame: baseline, 20 week
measure: frequency of minor allel
timeFrame: Baseline
Secondary outcomes:
measure: body mass(BM)
timeFrame: Baseline, 20 weeks
measure: Fat Free Mass (FFM)
timeFrame: Baseline, 20 weeks
measure: Fat Mass% (FM%)
timeFrame: Baseline, 20 weeks
measure: Total cholesterol (TChol)
timeFrame: Baseline, 20 weeks
measure: Blood HDL-cholesterol (HDL-C)
timeFrame: Baseline, 20 weeks
measure: Blood LDL-cholesterol (LDL-C)
timeFrame: Baseline, 20 weeks
measure: Blood triacylglycerol (TAG)
timeFrame: Baseline, 20 weeks
measure: Blood glucose (GLU)
timeFrame: Baseline, 20 weeks
measure: Insulin (INS)
timeFrame: Baseline, 20 week
measure: Dietary intake
timeFrame: Baseline
measure: aspartate aminotransferase (ASPAT)
timeFrame: Baseline, 20 weeks
measure: Alanine transaminase (ALAT)
timeFrame: Baseline, 20 weeks
measure: waist circumference (WC)
timeFrame: Baseline, 20 weeks
measure: hips circumference (HC)
timeFrame: Baseline, 20 weeks
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Science
name: Ewa Bulczak, Msc
role: PRINCIPAL_INVESTIGATOR
References: