university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 200)

The urine will be collected by the volunteers through the common sterile containers and data normalized for creatinine, after control with urine strip (11 parameters). After delivery, the saliva and urinary samples will be frozen and transported to the Center of Food Research and Nutrition (CREA-AN) for subsequent analysis. The composition of the oral microbiota will be evaluated through genomic DNA extraction from a salivary sample and subsequent Next Generation Sequencing analysis of the 16S ribosomal deoxyribonucleic acid (rDNA).

Medication Adherence

An in-depth analysis of the lifestyle of Italian and Spanish university students will be carried out for the first time, with assessment of the frequency of self-medication and use of drugs and supplements/nutraceuticals. The composition of the oral microbiota in relation to eating habits will be determined for the first time. The results of this study will be useful for designing promotion programs for the correct use of drugs/supplements and for healthy diets and lifestyles in university students

Lifestyle counseling

Research Centre for Food and Nutrition, Council for Agricultural Research and Economics (CREA-AN)

La Sapienza University

Universidad Catolica San Antonio de Murcia

Lifestyle, Self-medication and Use of Nutraceuticals in a Population of Italian and Spanish Students

Differences in Behaviour Related to Dietary Habit, Self-medication and Nutraceuticals Use Among Italian and Spanish University Students: Relationship With Cardiovascular Risk Factors.

The percentage of subjects who resort to self-medication and the use of drugs will be evaluated on the basis of the data reported in a specific online questionnaire

The use of alcoholic beverages will be evaluated with the questionnaire AUDIT, which will be included in the questionnaire on "voluptuous habits"

The use of energy drinks will be evaluated on the basis of the data reported in a specific online questionnaire

The use of supplements, dietary products and / or other types of nutraceuticals will be evaluated on the basis of the data reported in a specific online questionnaire

The degree of adherence to the Mediterranean diet (online questionnaire) will be calculated with two different scores: the Mediterranean Diet Score (MDS) evaluated through the validated 14-item questionnaire of the PREDIMED study and the MEDScore (Score-55) proposed by Panagiotakos with the dedicated software. The latter, unlike the first, includes the consumption of unrefined cereals. We will compare the baseline characteristics of participants according to three categories of adherence to the Mediterranean diet (> or egual to 5, 6-9 and > or egual to 10 points of the 14-item questionnaire). At each question of the 14-item questionnaire will be assigned a score of 0 or 1 on the basis of the answer. Panagiotakos et al. have already proposed a diet score that evaluates adherence to the Mediterranean diet through a large-scale (from 0 to 55).

Measurements of weight (Kg), height (m) (portable mechanical Stadiometer), lean mass and fat mass will be recorded on the data collection form. In particular, the latter will be measured both by means of the OMRON BF-511 body analysis impedance balance and by plicometry. Weight and height will be combined to report BMI in kg/m^2

Blood pressure will be recorded on the data collection form

The clinical metabolic status parameters will be evaluated by: self-diagnosis of capillary blood sampling (cholesterol, triglycerides and glycaemia by means of Multicare IN) and a dedicated ELISA kit for saliva sample insulin, based on saliva quality.

The clinical metabolic status parameter will be evaluated by self-diagnosis of capillary blood sampling (ketones by means of ON Call GK Dual)

The level of physical activity will be evaluated using the International Physical Activity Questionnaire (IPAQ, online questionnaire). It covers four domains of physical activity: work-related, transportation, housework/gardening and leisure-time activity. The questionnaire also includes questions about time spent sitting as an indicator of sedentary behaviour. In each of the four domains the number of days per week and time per day spent in both moderate and vigorous activity are recorded. At work, during transportation and in leisure time, walking time is also included. Moderate intensity is defined as 3-6 MET (Metabolic Equivalent Task) and vigorous intensity was defined as >6 MET. One MET is equal to energy expenditure during rest and is approximately equal to 3.5 ml O2 kg^-1 min^-1 in adults.

The frequence of orthorexia nervosa will be evaluated using the ORTO-15 test (online questionnaire).Answers that indicate orthorexia are given a score of "1", while the "healthier" ones have a score of "4". The sum of the scores is the final score of the test. We set a threshold value of 40. Below this cut-off the test is supposed to give a diagnosis of orthorexia.

Outcome Measure will be evaluated by online questionnaires

Other characeristics of interest will be evaluated by online questionnaires

Eating habits will be evaluated by online questionnaires

The composition of the oral microbiota will be evaluated through genomic DNA extraction from a salivary sample and subsequent Next Generation Sequencing analysis of the 16S rDNA.

Salivary IgA levels will be measured with ELISA kit

Salivary IL-6 levels will be measured with ELISA kit

Salivary cortisol levels will be measured with ELISA kit

The study will be articulated both in Italy and in Spain as follows:
2019-2020 phase Italy 2020-2021 phase Spain 2022 end of the study 2019-2022 publications and congresses

Maura Palmery

Associate Professor of Pharmacology

Universidad Católica San Antonio de Murcia

Research Centre for Food and Nutrition, CREA - AN

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)
Fish oil: Fish oil supplementation

Fish Oil

Olive oil supplements
Placebos: Olive Oil capsules

Placebo

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Marital Status

Change in total number of cigarettes per day from baseline to 4-weeks

Change in Cigarettes Per Day From Baseline to 4-weeks

Change in the Fagerström Test for Nicotine Dependency Score from baseline to 4-weeks. This scale is a validated instrument that measures nicotine dependency. The Fagerström Test for Nicotine Dependency is a 6-time survey. Each item is scores with a minimal score of 0 and a maximal score of 10. Higher scores indicate a higher level of nicotine dependency.

Change in Fagerström Scores From Baseline to 4-weeks

Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide

Point Prevalence Abstinence

Overall Study

Harvey J Murff

Placebos

Tobacco Use in Childbirth

Smoking Cessation

Pregnancy Related

Eligibility requirements requires participant to be pregnant

Fish oil

Vanderbilt University Medical Center

Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

This is a pilot and feasibility trial. We are not planning to share IPD with other researchers

Harvey Murff

Associate Professor

Randomized, double-blinded, placebo controlled trial

Double-blind, placebo control with medications dispensed by the Investigational Drug Service

Sitagliptin

Glimepiride

Duration of Type 2 diabetes

HbA1c

Pearson's correlation coefficient of HbA1c reduction with plasma levels of EPA and DHA at baseline

The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected.

The participants started glimepiride and continued the 16-week intervention with all pre-defined data collected.

Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction

Pearson's correlation coefficient of HbA1c reduction with estimated seafood intake

The participants started sitagliptin and continued the 16-week intervention with all pre-defined data collected

Correlation of Estimated Seafood Intake With HbA1c Reduction

Sitagliptin 50 mg a day for 16 weeks
Sitagliptin

Glimepiride 0.5 mg a day for 16 weeks
Glimepiride

Dr. Daisuke Yabe

The participants started sitagliptin at week 0

The participants started glimepiride at week 0

pufa/dental caries

Lifestyle, Self-medication and Use of Nutraceuticals in a Population of Italian and Spanish Students

Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes

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