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Personalized Nutrition Caffeine Intake in Healthy Adults.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122053
Enrollment
94
Registered
2019-10-10
Start date
2019-10-01
Completion date
2021-02-17
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYP1A2 Polymorphism

Keywords

intake, caffeine, coffee, genotype, personalized nutrition

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.

Interventions

BEHAVIORALIntervention 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.

BEHAVIORALControl 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.

Sponsors

Poznan University of Life Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Caffeine intake level from dietary sourcesbaseline, 20 weekcaffeine intake (mg/day)
frequency of minor allelBaselinegenotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes

Secondary

MeasureTime frameDescription
Blood HDL-cholesterol (HDL-C)Baseline, 20 weeksHDL-C (mg/dl) concentrations change within the group and between the groups
Blood LDL-cholesterol (LDL-C)Baseline, 20 weeksLDL-C (mg/dl) concentrations change within the group and between the groups
Fat Free Mass (FFM)Baseline, 20 weeksFFM changes within (kg) groups and between groups
Fat Mass% (FM%)Baseline, 20 weeksFM% changes within groups and between groups
Blood triacylglycerol (TAG)Baseline, 20 weeksTAG (mg/dl) concentrations change within the group and between the groups
Blood glucose (GLU)Baseline, 20 weeksGLU (mg/dl) concentrations change within the group and between the groups
body mass(BM)Baseline, 20 weeksChanges in BM (kg) within groups and between groups
Dietary intakeBaselinemacro and micronutrient intake (g,mg,ug)
aspartate aminotransferase (ASPAT)Baseline, 20 weeksASPAT \[U/l\] Changes within groups and between groups
Alanine transaminase (ALAT)Baseline, 20 weeksALAT \[U/l\] Changes within groups and between groups
waist circumference (WC)Baseline, 20 weeksWC (cm) Changes within groups and between groups
hips circumference (HC)Baseline, 20 weeksHC (cm) changes within groups and between groups
Insulin (INS)Baseline, 20 weekINS (ulU/ml) concentrations change within the group and between the groups
Total cholesterol (TChol)Baseline, 20 weeksChanges in TChol (mg/dl) within groups and between groups

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026