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

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.

Study Overview

• Status: Completed
• Conditions: CYP1A2 Polymorphism
• Intervention / Treatment: Behavioral: Intervention group with genotype information; Behavioral: Control group without genotype information

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland
    • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass(BM)	Changes in BM (kg) within groups and between groups	Baseline, 20 weeks
Fat Free Mass (FFM)	FFM changes within (kg) groups and between groups	Baseline, 20 weeks
Fat Mass% (FM%)	FM% changes within groups and between groups	Baseline, 20 weeks
Total cholesterol (TChol)	Changes in TChol (mg/dl) within groups and between groups	Baseline, 20 weeks
Blood HDL-cholesterol (HDL-C)	HDL-C (mg/dl) concentrations change within the group and between the groups	Baseline, 20 weeks
Blood LDL-cholesterol (LDL-C)	LDL-C (mg/dl) concentrations change within the group and between the groups	Baseline, 20 weeks
Blood triacylglycerol (TAG)	TAG (mg/dl) concentrations change within the group and between the groups	Baseline, 20 weeks
Blood glucose (GLU)	GLU (mg/dl) concentrations change within the group and between the groups	Baseline, 20 weeks
Insulin (INS)	INS (ulU/ml) concentrations change within the group and between the groups	Baseline, 20 week
Dietary intake	macro and micronutrient intake (g,mg,ug)	Baseline
aspartate aminotransferase (ASPAT)	ASPAT [U/l] Changes within groups and between groups	Baseline, 20 weeks
Alanine transaminase (ALAT)	ALAT [U/l] Changes within groups and between groups	Baseline, 20 weeks
waist circumference (WC)	WC (cm) Changes within groups and between groups	Baseline, 20 weeks
hips circumference (HC)	HC (cm) changes within groups and between groups	Baseline, 20 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 17, 2021
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: caffeine; coffee; personalized nutrition; genotype; intake
• Other Study ID Numbers: UKB196/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No