Personalized Nutrition Caffeine Intake in Healthy Adults.

Sponsor
Poznan University of Life Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04122053
Collaborator
(none)
94
1
2
16.6
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention group with genotype information
  • Behavioral: Control group without genotype information
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 informationeligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Can Including Genotype Information Increase the Effectiveness of Dietary Interventions? Polymorphism of the CYP1A2 Gene and Caffeine Intake in Healthy Adults
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Feb 17, 2021
Actual Study Completion Date :
Feb 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

group will receive dietary advice and genotype information

Behavioral: Intervention 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.

Active Comparator: Control group

group will receive dietary advice

Behavioral: Control 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.

Outcome Measures

Primary Outcome Measures

  1. Caffeine intake level from dietary sources [baseline, 20 week]

    caffeine intake (mg/day)

  2. frequency of minor allel [Baseline]

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

Secondary Outcome Measures

  1. body mass(BM) [Baseline, 20 weeks]

    Changes in BM (kg) within groups and between groups

  2. Fat Free Mass (FFM) [Baseline, 20 weeks]

    FFM changes within (kg) groups and between groups

  3. Fat Mass% (FM%) [Baseline, 20 weeks]

    FM% changes within groups and between groups

  4. Total cholesterol (TChol) [Baseline, 20 weeks]

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

  5. Blood HDL-cholesterol (HDL-C) [Baseline, 20 weeks]

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

  6. Blood LDL-cholesterol (LDL-C) [Baseline, 20 weeks]

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

  7. Blood triacylglycerol (TAG) [Baseline, 20 weeks]

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

  8. Blood glucose (GLU) [Baseline, 20 weeks]

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

  9. Insulin (INS) [Baseline, 20 week]

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

  10. Dietary intake [Baseline]

    macro and micronutrient intake (g,mg,ug)

  11. aspartate aminotransferase (ASPAT) [Baseline, 20 weeks]

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

  12. Alanine transaminase (ALAT) [Baseline, 20 weeks]

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

  13. waist circumference (WC) [Baseline, 20 weeks]

    WC (cm) Changes within groups and between groups

  14. hips circumference (HC) [Baseline, 20 weeks]

    HC (cm) changes within groups and between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Poznan University of Life Sciences Poznań Poland

Sponsors and Collaborators

  • Poznan University of Life Sciences

Investigators

  • Principal Investigator: Ewa Bulczak, Msc, Poznan University of Life Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Agata Chmurzyńska, Professor, Poznan University of Life Sciences
ClinicalTrials.gov Identifier:
NCT04122053
Other Study ID Numbers:
  • UKB196/19
First Posted:
Oct 10, 2019
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Agata Chmurzyńska, Professor, Poznan University of Life Sciences

Study Results

No Results Posted as of Feb 18, 2022