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

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ClinicalTrials.gov Identifier: NCT04099420
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Universidad Católica San Antonio de Murcia
Research Centre for Food and Nutrition, CREA - AN
Information provided by (Responsible Party):
Maura Palmery, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment
Medication Adherence Behavioral: Lifestyle counseling

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Differences in Behaviour Related to Dietary Habit, Self-medication and Nutraceuticals Use Among Italian and Spanish University Students: Relationship With Cardiovascular Risk Factors.
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2022

Group/Cohort Intervention/treatment
Italian university students
university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 200)
Behavioral: Lifestyle counseling
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

Spanish university students
university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 200)
Behavioral: Lifestyle counseling
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




Primary Outcome Measures :
  1. Compare the prescription of drugs in Italian and Spanish university students [ Time Frame: One year ]
    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

  2. Compare the use of alcohol in Italian and Spanish university students [ Time Frame: One year ]
    The use of alcoholic beverages will be evaluated with the questionnaire AUDIT, which will be included in the questionnaire on "voluptuous habits"

  3. Compare the use of energy drinks in Italian and Spanish university students [ Time Frame: One year ]
    The use of energy drinks will be evaluated on the basis of the data reported in a specific online questionnaire

  4. Compare the use of supplements, dietary products and/or other types of nutraceuticals in Italian and Spanish university students [ Time Frame: One year ]
    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

  5. Compare the adherence to the Mediterranean diet in Italian and Spanish university students [ Time Frame: One year ]
    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).

  6. Compare cardiovascular risk factors (obesity) in Italian and Spanish university students [ Time Frame: Two year ]
    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

  7. Compare cardiovascular risk factors (hypertension) in Italian and Spanish university students [ Time Frame: Two year ]
    Blood pressure will be recorded on the data collection form

  8. Compare cardiovascular risk factors (hyperglycemia and dyslipidemia) in Italian and Spanish university students [ Time Frame: Two year ]
    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.

  9. Compare ketosis in Italian and Spanish university students [ Time Frame: Two year ]
    The clinical metabolic status parameter will be evaluated by self-diagnosis of capillary blood sampling (ketones by means of ON Call GK Dual)


Secondary Outcome Measures :
  1. Compare and evaluate the level of physical activity in Italian and Spanish university students [ Time Frame: One year ]
    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.

  2. Compare and evaluate the percentage of subjects with orthorexia nervosa in Italian and Spanish university students [ Time Frame: One year ]
    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.

  3. Compare the frequency of meals consumed outside home in Italian and Spanish university students [ Time Frame: One year ]
    Outcome Measure will be evaluated by online questionnaires

  4. Compare the type of meals consumed outside home in Italian and Spanish university students [ Time Frame: One year ]
    Outcome Measure will be evaluated by online questionnaires

  5. Compare the type of food/beverages consumed in Italian and Spanish university students [ Time Frame: One year ]
    Outcome Measure will be evaluated by online questionnaires

  6. Compare the consumption of food/beverages in Italian and Spanish university students [ Time Frame: One year ]
    Outcome Measure will be evaluated by online questionnaires

  7. Compare the adherence to special dietary regimes (vegetarian diet, ketogenic etc) in Italian and Spanish university students [ Time Frame: One year ]
    Outcome Measure will be evaluated by online questionnaires

  8. Register other characteristics of interest (pathologies) [ Time Frame: One year ]
    Other characeristics of interest will be evaluated by online questionnaires

  9. Register other characteristics of interest (anxiety/depressive symptoms) [ Time Frame: One year ]
    Other characeristics of interest will be evaluated by online questionnaires

  10. Register other characteristics of interest (food neophobia) [ Time Frame: One year ]
    Other characeristics of interest will be evaluated by online questionnaires

  11. Register other characteristics of interest (eating disorders) [ Time Frame: One year ]
    Other characeristics of interest will be evaluated by online questionnaires

  12. Register other characteristics of interest (vaccinations and opinion on vaccines) [ Time Frame: One year ]
    Other characeristics of interest will be evaluated by online questionnaires

  13. Compare eating habits in a sub-group of non-smoking Italian and Spanish students [ Time Frame: Two year ]
    Eating habits will be evaluated by online questionnaires

  14. Compare salivary microbiota in a sub-group of non-smoking Italian and Spanish students [ Time Frame: Two year ]
    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.

  15. Compare salivary IgA levels in a sub-group of non-smoking Italian and Spanish students [ Time Frame: Two year ]
    Salivary IgA levels will be measured with ELISA kit

  16. Compare salivary IL-6 levels in a sub-group of non-smoking Italian and Spanish students [ Time Frame: Two year ]
    Salivary IL-6 levels will be measured with ELISA kit

  17. Compare salivary cortisol levels in a sub-group of non-smoking Italian and Spanish students [ Time Frame: Two year ]
    Salivary cortisol levels will be measured with ELISA kit


Biospecimen Retention:   Samples With DNA

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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

University students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 400, 200 Italian and 200 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)

Criteria

Inclusion Criteria:

  • university students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences

Exclusion Criteria:

  • age <18 years or inability to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099420


Contacts
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Contact: Paola Aiello, PhD student 3385733844 ext +39 paola.aiello@uniroma1.it
Contact: Ilaria Peluso, Researcher 3296131353 ext +39 ilaria.peluso@crea.gov.it

Locations
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Italy
Research Centre for Food and Nutrition, Council for Agricultural Research and Economics (CREA-AN) Active, not recruiting
Rome, Italy, 00178
La Sapienza University Recruiting
Rome, Italy, 00185
Contact: Paola Aiello, PhD student    338 573 3844 ext +39    paola.aiello@uniroma1.it   
Contact: Maura Palmery, Professor    335 781 8893 ext +39    maura.palmery@uniroma1.it   
Spain
Universidad Catolica San Antonio de Murcia Not yet recruiting
Murcia, Guadalupe, Spain, 30107
Contact: Paola Aiello, PhD student    338 573 3844 ext +39    paiello@alu.ucam.edu   
Contact: Débora V Valencia, Professor       dvillano@ucam.edu   
Sponsors and Collaborators
Maura Palmery
Universidad Católica San Antonio de Murcia
Research Centre for Food and Nutrition, CREA - AN
Investigators
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Study Director: Maura Palmery, Professor La Sapienza University of Rome, Italy
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Responsible Party: Maura Palmery, Associate Professor of Pharmacology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04099420    
Other Study ID Numbers: 1382/2019
CE071906 ( Other Identifier: Universidad Católica San Antonio de Murcia (UCAM) )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maura Palmery, University of Roma La Sapienza:
Self-medication
Adherence to Mediterranean diet
Orthorexia
Relationship lifestyle and metabolic status biomarkers
Oral microbiota composition
Relationship lifestyle and immunological status biomarkers