There are 2 clinical trials
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.
genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes.
Description: caffeine intake (mg/day)
Measure: Caffeine intake level from dietary sources Time: 8 weeksDescription: genotyping for CYP1A2 polymorphism (rs762551); assessment of possible genotypes (AA, AC, CC) will be performed with the use of TaqMan probes
Measure: frequency of minor allel Time: BaselineDescription: Changes in BM (kg) within groups and between groups
Measure: body mass(BM) Time: Baseline, 8 weeksDescription: FFM changes within (kg) groups and between groups
Measure: Fat Free Mass (FFM) Time: Baseline, 8 weeksDescription: FM% changes within groups and between groups
Measure: Fat Mass% (FM%) Time: Baseline, 8 weeksDescription: Changes in TChol (mg/dl) within groups and between groups
Measure: Total cholesterol (TChol) Time: Baseline, 8 weeksDescription: HDL-C (mg/dl) concentrations change within the group and between the groups
Measure: Blood HDL-cholesterol (HDL-C) Time: Baseline, 8 weeksDescription: LDL-C (mg/dl) concentrations change within the group and between the groups
Measure: Blood LDL-cholesterol (LDL-C) Time: Baseline, 8 weeksDescription: TAG (mg/dl) concentrations change within the group and between the groups
Measure: Blood triacylglycerol (TAG) Time: Baseline, 8 weeksDescription: GLU (mg/dl) concentrations change within the group and between the groups
Measure: Blood glucose (GLU) Time: Baseline, 8 weeksDescription: INS (ulU/ml) concentrations change within the group and between the groups
Measure: Insulin (INS) Time: Baseline, 8 weekDescription: macro and micronutrient intake (g,mg,ug)
Measure: Dietary intake Time: BaselineDescription: ASPAT [U/l] Changes within groups and between groups
Measure: aspartate aminotransferase (ASPAT) Time: Baseline, 8 weeksDescription: ALAT [U/l] Changes within groups and between groups
Measure: Alanine transaminase (ALAT) Time: Baseline, 8 weeksDescription: WC (cm) Changes within groups and between groups
Measure: waist circumference (WC) Time: Baseline, 8 weeksDescription: HC (cm) changes within groups and between groups
Measure: hips circumference (HC) Time: Baseline, 8 weeksClozapine (Clz), an atypical antipsychotic, is the reference medication for patients with treatment-resistant schizophrenia. Due to the high inter-individual variability of its pharmacokinetics and its narrow therapeutic index, a close therapeutic drug monitoring (TDM) of Clz is highly recommended. Several factors can cause a variation in the pharmacokinetics as age, smoking habits, coffee consumption and drug interaction. Genetic factors related to hepatic expression levels of the cytochrome P450 (CYP), regulate the hepatic clearance of Clz, thereby determine its bioavailability. The CYP1A2 and CYP2C19 isoenzymes are mainly responsible for the metabolism of several drugs including Clz. It has been demonstrated that there is an interethnic variation in the expression and function of these two isoenzymes. This variation is caused by single nucleotide polymorphisms (SNPs) of genes encoding these proteins. While the Influence of the different polymorphisms related to CYP1A2 and CYP2C19 have been established especially in Asian and Caucasian populations, no study has examined the impact of these SNPs in the southern Mediterranean populations. Moreover, the impact of these SNPs is very controversial. The present study aims to investigate in Tunisian schizophrenic patients, the influence of genetic (CYP1A2 and CYP2C19 polymorphisms) and non-genetic factors on Clz pharmacokinetics.
Determination of the correlation between the presence of CYP1A2*1F (rs762551;-163C> A), CYP1A2*1C (rs2069514;-3860 G> A) and CYP 2C19*2 (rs4244285; 681G>A) and the variability of C0/Daily dose.. - Technique: PCR-RFLP (Polymerase Chain Reaction-Restriction Fragment Length Polymorphism).
Description: Technique : HPLC/UV (high-performance liquid chromatography associated with a UV detector)
Measure: Determination of trough plasma concentration of clozapine (C0) Time: One and a half monthsDescription: - Technique: PCR-RFLP (Polymerase Chain Reaction-Restriction Fragment Length Polymorphism)
Measure: Determination of the correlation between the presence of CYP1A2*1F (rs762551;-163C> A), CYP1A2*1C (rs2069514;-3860 G> A) and CYP 2C19*2 (rs4244285; 681G>A) and the variability of C0/Daily dose. Time: One and a half months