Personalized Nutrition Caffeine Intake in Healthy Adults.

NCT04122053 | Completed

• 1 other identifier: UKB196/19
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

CYP1A2 Polymorphism

Keywords

intake; caffeine; coffee; genotype; personalized nutrition

Outcome Measures

Primary Outcomes (2)

• Caffeine intake level from dietary sources

  caffeine intake (mg/day)

  baseline, 20 week

• frequency of minor allel

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

  Baseline

Secondary Outcomes (14)

• body mass(BM)

  Baseline, 20 weeks

• Fat Free Mass (FFM)

  Baseline, 20 weeks

• Fat Mass% (FM%)

  Baseline, 20 weeks

• Total cholesterol (TChol)

  Baseline, 20 weeks

• Blood HDL-cholesterol (HDL-C)

  Baseline, 20 weeks

Study Arms (2)

study group

EXPERIMENTAL

group will receive dietary advice and genotype information

Behavioral: Intervention group with genotype information

Control group

ACTIVE COMPARATOR

group will receive dietary advice

Behavioral: Control group without genotype information

Interventions

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.

study group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-60
• daily coffee intake at a minimum 2 cups (or equivalent total caffeine intake)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, Poland

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ewa Bulczak, Msc

  Poznan University of Life Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 10, 2019
• Study Start: October 1, 2019
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)