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Report for Clinical Trial NCT04122053

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04122053 CYP1A2 Polymorphism

2 Interventions

Name: Intervention group with genotype information

Description: 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.
Type: Behavioral
Group Labels: 1

study group

Name: Control group without genotype information

Description: 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.
Type: Behavioral
Group Labels: 1

Control group

Primary Outcomes

Description: caffeine intake (mg/day)

Measure: Caffeine intake level from dietary sources

Time: 8 weeks

Description: genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes

Measure: frequency of minor allel

Time: Baseline

Secondary Outcomes

Description: Changes in BM (kg) within groups and between groups

Measure: body mass(BM)

Time: Baseline, 8 weeks

Description: FFM changes within (kg) groups and between groups

Measure: Fat Free Mass (FFM)

Time: Baseline, 8 weeks

Description: FM% changes within groups and between groups

Measure: Fat Mass% (FM%)

Time: Baseline, 8 weeks

Description: Changes in TChol (mg/dl) within groups and between groups

Measure: Total cholesterol (TChol)

Time: Baseline, 8 weeks

Description: HDL-C (mg/dl) concentrations change within the group and between the groups

Measure: Blood HDL-cholesterol (HDL-C)

Time: Baseline, 8 weeks

Description: LDL-C (mg/dl) concentrations change within the group and between the groups

Measure: Blood LDL-cholesterol (LDL-C)

Time: Baseline, 8 weeks

Description: TAG (mg/dl) concentrations change within the group and between the groups

Measure: Blood triacylglycerol (TAG)

Time: Baseline, 8 weeks

Description: GLU (mg/dl) concentrations change within the group and between the groups

Measure: Blood glucose (GLU)

Time: Baseline, 8 weeks

Description: INS (ulU/ml) concentrations change within the group and between the groups

Measure: Insulin (INS)

Time: Baseline, 8 week

Description: macro and micronutrient intake (g,mg,ug)

Measure: Dietary intake

Time: Baseline

Description: ASPAT [U/l] Changes within groups and between groups

Measure: aspartate aminotransferase (ASPAT)

Time: Baseline, 8 weeks

Description: ALAT [U/l] Changes within groups and between groups

Measure: Alanine transaminase (ALAT)

Time: Baseline, 8 weeks

Description: WC (cm) Changes within groups and between groups

Measure: waist circumference (WC)

Time: Baseline, 8 weeks

Description: HC (cm) changes within groups and between groups

Measure: hips circumference (HC)

Time: Baseline, 8 weeks
Purpose: Basic Science

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs762551

genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes.


HPO Nodes