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Completed

NCT Number: NCT04122053

Personalized Nutrition 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.

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Key information

Conditions

CYP1A2 Polymorphism

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group with genotype information

Behavioral

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.

Control group without genotype information

Behavioral

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.

Primary outcomes

  1. Caffeine intake level from dietary sources

    Time frame: baseline, 20 week

    caffeine intake (mg/day)

  2. 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

  1. body mass(BM)

    Time frame: Baseline, 20 weeks

    Changes in BM (kg) within groups and between groups

  2. Fat Free Mass (FFM)

    Time frame: Baseline, 20 weeks

    FFM changes within (kg) groups and between groups

  3. Fat Mass% (FM%)

    Time frame: Baseline, 20 weeks

    FM% changes within groups and between groups

  4. Total cholesterol (TChol)

    Time frame: Baseline, 20 weeks

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

  5. Blood HDL-cholesterol (HDL-C)

    Time frame: Baseline, 20 weeks

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

  6. Blood LDL-cholesterol (LDL-C)

    Time frame: Baseline, 20 weeks

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

  7. Blood triacylglycerol (TAG)

    Time frame: Baseline, 20 weeks

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

  8. Blood glucose (GLU)

    Time frame: Baseline, 20 weeks

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

  9. Insulin (INS)

    Time frame: Baseline, 20 week

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

  10. Dietary intake

    Time frame: Baseline

    macro and micronutrient intake (g,mg,ug)

  11. aspartate aminotransferase (ASPAT)

    Time frame: Baseline, 20 weeks

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

  12. Alanine transaminase (ALAT)

    Time frame: Baseline, 20 weeks

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

  13. waist circumference (WC)

    Time frame: Baseline, 20 weeks

    WC (cm) Changes within groups and between groups

  14. hips circumference (HC)

    Time frame: Baseline, 20 weeks

    HC (cm) changes within groups and between groups

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2019
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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