Personalized Nutrition Caffeine Intake in Healthy Adults.

CYP1A2 Polymorphism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122053
• Other study ID #: UKB196/19
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 17, 2021

Study information

• Verified date: February 2022
• Source: Poznan University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• CYP1A2 Polymorphism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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