Lifestyle, Self-medication and Use of Nutraceuticals in a Population of Italian and Spanish Students
STANIS
Differences in Behaviour Related to Dietary Habit, Self-medication and Nutraceuticals Use Among Italian and Spanish University Students: Relationship With Cardiovascular Risk Factors.
2 other identifiers
observational
200
2 countries
3
Brief Summary
University students are considered a population class with a high risk of malnutrition and/or obesity, metabolic and cardiovascular diseases, with a tendency to misuse drugs and self-medication. The interest in a healthy diet can lead to a psychological obsession known as orthorexia, frequent among students in the biomedical field and in the sports context. The high levels of stress recorded in university students have been related to the use of drugs to enhance their cognitive abilities. The phenomenon of self-medication is one of the main problems for public health, with high levels recorded among students of health professions. A high adherence to the Mediterranean diet seems to bring health benefits, with an impact even on the intestinal microbiota composition. Although several studies have investigated the effect of the Mediterranean diet on intestinal microbiota, little attention has been paid to the effect of this diet on the oral microbiota, one of the most relevant microbial habitats from a clinical point of view. The aim of this study is to evaluate self-medication, adherence to the Mediterranean diet, the relationship between lifestyle and biomarkers of the metabolic and immunological status, and impact of eating habits on the oral microbiota composition. Students, doctoral students, post-docs and specialists in the biomedical and pharmaceutical fields will be recruited in Italy (N = 200) and in Spain (N = 200). Data will be collected through questionnaires in order to evaluate self-medication, eating habits, level of physical activity, orthorexia and lifestyle of the subjects. The entire group will be evaluated with clinical parameters of metabolic status and the quality of saliva and urine. The latter will be determining factors for the selection of 50 Italian and 50 Spanish students, on which parameters of immunological and antioxidant status, cortisol, urinary phenols, and the composition of the oral microbiota will be evaluated. Italian and Spanish students may have different eating habits and lifestyles. It is assumed that subjects with high adherence to the Mediterranean diet have a better metabolic and immunological status. Moreover, high rates of orthorexia are expected among students who practice sports. The composition of the oral microbiota could vary depending on the type of diet and consistently with the immunological status markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2019
CompletedFirst Submitted
Initial submission to the registry
August 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedNovember 4, 2020
November 1, 2020
2 years
August 18, 2019
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Compare the prescription of drugs in Italian and Spanish university students
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
One year
Compare the use of alcohol in Italian and Spanish university students
The use of alcoholic beverages will be evaluated with the questionnaire AUDIT, which will be included in the questionnaire on "voluptuous habits"
One year
Compare the use of energy drinks in Italian and Spanish university students
The use of energy drinks will be evaluated on the basis of the data reported in a specific online questionnaire
One year
Compare the use of supplements, dietary products and/or other types of nutraceuticals in Italian and Spanish university students
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
One year
Compare the adherence to the Mediterranean diet in Italian and Spanish university students
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).
One year
Compare cardiovascular risk factors (obesity) in Italian and Spanish university students
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
Two year
Compare cardiovascular risk factors (hypertension) in Italian and Spanish university students
Blood pressure will be recorded on the data collection form
Two year
Compare cardiovascular risk factors (hyperglycemia and dyslipidemia) in Italian and Spanish university students
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.
Two year
Compare ketosis in Italian and Spanish university students
The clinical metabolic status parameter will be evaluated by self-diagnosis of capillary blood sampling (ketones by means of ON Call GK Dual)
Two year
Secondary Outcomes (17)
Compare and evaluate the level of physical activity in Italian and Spanish university students
One year
Compare and evaluate the percentage of subjects with orthorexia nervosa in Italian and Spanish university students
One year
Compare the frequency of meals consumed outside home in Italian and Spanish university students
One year
Compare the type of meals consumed outside home in Italian and Spanish university students
One year
Compare the type of food/beverages consumed in Italian and Spanish university students
One year
- +12 more secondary outcomes
Study Arms (2)
Italian university students
university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 100)
Spanish university students
university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 100)
Interventions
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
Eligibility Criteria
University students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 200, 100 Italian and 100 Spanish). The sample size was chosen based on previous studies conducted on university students. If no significant differences were found for the markers for which there is no supporting literature, the sample size will be calculated for subsequent studies, setting a desidered power 0.8 with an alpha = 0.05, based on the average difference and the standard deviation of the compared groups (Italian and Spanish students in relation to the degree of adherence to the Mediterranean diet)
You may qualify if:
- university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences
You may not qualify if:
- age \<18 years or inability to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maura Palmerylead
- Universidad Católica San Antonio de Murciacollaborator
- Research Centre for Food and Nutrition, CREA - ANcollaborator
Study Sites (3)
Research Centre for Food and Nutrition, Council for Agricultural Research and Economics (CREA-AN)
Rome, 00178, Italy
La Sapienza University
Rome, 00185, Italy
Universidad Catolica San Antonio de Murcia
Murcia, Guadalupe, 30107, Spain
Biospecimen
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).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maura Palmery, Professor
La Sapienza University of Rome, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Pharmacology
Study Record Dates
First Submitted
August 18, 2019
First Posted
September 23, 2019
Study Start
July 17, 2019
Primary Completion
July 31, 2021
Study Completion
July 31, 2022
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
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