AzTrials
AzTrials

Medication AdherenceSTANISNCT04099420

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

An observational study of Medication Adherence, run by Maura Palmery at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Medication Adherence
What is being tested?
Lifestyle counseling
How many people
200 participants
Where
3 sitesin 2 countries
Study dates
17 Jul 2019to 31 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

Paola Aiello, PhD student contact

3385733844 ext. +39

paola.aiello@uniroma1.it

Ilaria Peluso, Researcher contact

3296131353 ext. +39

ilaria.peluso@crea.gov.it

3 sites in 2 countries

Italy2 sites, 1 recruiting
  • Research Centre for Food and Nutrition, Council for Agricultural Research and Economics (CREA-AN)

    Rome, 00178

    Active, not recruiting
  • La Sapienza University

    Rome, 00185

    Paola Aiello, PhD student, 338 573 3844 ext. +39, paola.aiello@uniroma1.it

    Maura Palmery, Professor, 335 781 8893 ext. +39, maura.palmery@uniroma1.it

    Recruiting

Other trials in Italy

Spain1 site, 1 recruiting
  • Universidad Catolica San Antonio de Murcia

    Murcia, Guadalupe, 30107

    Paola Aiello, PhD student, 338 573 3844 ext. +39, paiello@alu.ucam.edu

    Débora V Valencia, Professor, dvillano@ucam.edu

    Not yet recruiting

Other trials in Spain

About this study

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.

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.

Read more

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.

Read the detailed description

Young people are considered a population at risk of nutritional deficiencies due to bad eating habits, found especially among university students. In fact, the latter tend to change their eating habits when they begin their university studies, with adherence to a typically western diet that includes low consumption of fish, fruit and vegetables, monounsaturated and polyunsaturated fatty acids, and an increase in consumption of sugars, alcohol and "fast food", with the consequent increase in this population class of the risk of malnutrition and/or obesity, metabolic and cardiovascular diseases. These changes are due to the lack of experience in meal planning, with a consequent increase in the frequency of meals away from home, to the increase in the number of snacks or meals skipped to respect the timetable of the lessons, to the easier access to the fast food and limited economic resources. Among the unhealthy behaviors adopted by the students, in addition to the wrong eating habits, there are also reduced physical activity, increased sedentariness, alcohol consumption and smoking.

Over the past 20 years there has been an increase in obesity rates among university students who, especially for medical students, are closely related to specific habits such as: skipping breakfast, attending fast food, low fruit and vegetables consumption, and easy access to unhealthy foods from the machines. Among the freshmen, especially those who live far from families and find themselves independent for the first time in their lives, higher rates of weight gain and higher levels of stress have been reported, responsible for changes in food choices. In fact, to control stress levels, individuals are encouraged to prefer foods that are high in fat. Therefore, university students should be seen as a group that requires special attention regarding health promotion, especially food.

However, the interest in a healthy diet can lead to a psychological obsession known as orthorexia (ortho = just, oreksis = appetite), which consists in the persistent concern of maintaining the self-imposed diet to improve one's health. Nutritionists/dieticians and students are the categories of population most affected by orthorexia, with a prevalence in Italian nutrition science students of 35.9%. The typical behaviors of orthorexia can be associated with a negative image of one's own body, despite the subject's strong interest in appropriate and healthy food choices. However, as a result of extreme restriction/concern over one's diet, orthorhexics would tend to eliminate whole groups of foods with consequent nutritional deficiencies, malnutrition and weight loss. Furthermore, the typical eating behavior of orthoressia is associated with intense physical activity, suggesting that students who practice sports have a greater tendency to develop this disorder.

The high levels of stress recorded in university students were also related to the use of smart drugs and "smart nutrients", which university students, especially those in medicine (74.7%), use to enhance their cognitive abilities. The phenomenon of self-medication is one of the main problems for public health, with only 48% of the population of the European Union using prescribed drugs. Among the students of health professions high levels of self-medication with antibiotics are recorded in the absence of indication. Another trend that is of particular concern is the increase in the use of antidepressants among young people, which many of them take after disappointments in academic performance and which have negative side effects such as weight gain , altered lipid profile and risk of diabetes. Another category of substances that young people abuse or otherwise misuse are amphetamines, and the co-intake of stimulants, alcohol or other drugs is also of concern. Indeed, a recent study carried out on Italian and Spanish pharmacy students showed that Spaniards have a high percentage of drug use and that 38.4% of subjects take them in conjunction with alcohol; instead, Italian students have revealed that they rarely turn to the pharmacist and rely more on the advice of family or friends.

The university years therefore represent a period marked not only by food problems but also by stress, anxiety, depression and other psychological problems. However, it emerged that a high adherence to the Mediterranean diet would bring benefits at the cognitive level, with an improvement in the states of depression and anxiety and a better academic result. In addition to a healthy diet, even moderate and regular physical activity (90 minutes a week) has been shown to reduce levels of anxiety and depression with improved well-being and self-esteem. For this reason it is essential to promote this lifestyle among university students.

Different types of diet and bioactive compounds taken with the diet can also have an impact on the composition of the intestinal microbiota. In particular, the Mediterranean diet has been associated with a greater abundance of Bacteroidetes, Prevotellacea and Prevotella and a lower concentration of Firmicutes and Lachnospiraceae. Although several studies have investigated the eating habits of Spanish university students, only Scuri et al. investigated the use of drugs in Italian and Spanish university students, but limited the study to a well-defined sample represented by students of the only pharmacy faculty, because they were considered particularly careful and involved on this topic. It would therefore be interesting to evaluate this behaviour, including the tendency to self-medication, between Italian and Spanish students, including biomedical and not just pharmaceutical faculties, in order to have an overview of the behaviour of university students who support scientific studies, that should lead them to acquire more awareness of health problems, including the correct use of drugs. Furthermore, 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, despite the oral cavity being one of the most relevant microbial habitats from a clinical point of view, and it has been shown to be a significant risk factor for cardiovascular diseases, diabetes mellitus, bacteraemia and tumors. It is therefore interesting to analyse and investigate these aspects.

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.

Primary goals:

  • Compare the prescription of drugs and the use of alcohol, energy drinks, supplements, dietary products and/or other types of nutraceuticals in Italian and Spanish university students.
  • Compare the adherence to the Mediterranean diet in Italian and Spanish university students.
  • Compare cardiovascular risk factors (obesity, hypertension, hyperglycemia, dyslipidemia and smoking habits) and ketosis in Italian and Spanish university students.

Secondary goals:

  • Compare and evaluate the level of physical activity and the percentage of subjects with orthorexia nervosa in Italian and Spanish university students.
  • Compare the frequency and type of meals consumed outside home, the type and consumption of food/beverages and adherence to special dietary regimes (vegetarian diet, ketogenic etc), in Italian and Spanish university students.
  • Register other characteristics of interest (pathologies, anxiety/depressive symptoms, food neophobia, eating disorders, vaccinations and opinion on vaccines).
  • Compare eating habits, salivary microbiota and salivary immunoglobulin A (IgA), interleukin-6 (IL-6) and cortisol levels in a sub-group of non-smoking Italian and Spanish students.

In the recruitment phase it will be sent to the subjects by e-mail:

  • "The" INFORMATION NOTE AND CONSENT "
  • "Food Diary" (optional completion)

From the time of recruitment to enrolling (first meeting) the volunteers will be able to calmly and carefully read the "INFORMATION AND CONSENT NOTE". The subjects may also request clarifications or details from the recruiter and/or the person in charge of the study. Moreover, before deciding, the volunteers will have time to ask an opinion to family or to a doctor of their trust.

The recruiters will make contact with the volunteers, collect the data and assign a code to the volunteer.

The standard data flow at the first, second and third meeting will be as follows:

First meeting:

  1. Signed informed consent at the time of enrollment.
  2. Compilation of the "Code sheet"
  3. Withdrawal and control of the "food diary"
  4. Filling in questionnaires
  5. Anthropometric and arterial pressure measurements

Second meeting:

  1. New notice of the information note and informed consent signature
  2. Administration of the Food Frequency Questionnaire (FFQ) (http://www.sisdca.it/public/pdf/IDAO---testistica.pdf) with the aid of the Scotti Bassani portant atlas (http: // www .giorgiobedogni.it / archives / text / atlas / patlante.html)
  3. Collection of saliva samples to assess their quality and for subsequent analysis
  4. Delivery container for collection of urine and those for the collection of saliva for circadian cortisol.

Third meeting:

  1. New notice of the information note and informed consent signature
  2. Delivery of urine and saliva samples collected
  3. Measurement of metabolic state parameters (cholesterol, triglycerides, glycemia and ketones)

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. This study should also confirm the results of previous studies on the high rate of orthorexia in biomedical faculty students, especially among nutritionists and sports practitioners. The results of this study will also be useful for designing promotion programs for the correct use of drugs/supplements and for healthy diets and lifestyles in university students, and will also provide a potentially useful basis for the recruitment of subjects in additional/future intervention studies.

Being tested
Lifestyle counseling
Keywords
Self-medication, Adherence to Mediterranean diet, Orthorexia, Relationship lifestyle and metabolic status biomarkers, Oral microbiota composition, Relationship lifestyle and immunological status biomarkers
Medical subject headings
Medication Adherence, Orthorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle counselingBehavioural

    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

Study groups in NCT04099420
Study groupRoleWhat they receive
Italian university studentsuniversity students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 100)
Receives: Behavioral: Lifestyle counseling
Spanish university studentsuniversity students, doctoral students, post-docs and post-graduate students in biomedical and pharmaceutical sciences (N = 100)
Receives: Behavioral: Lifestyle counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: One year

  2. 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"

    Measured: One year

  3. 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

    Measured: One year

  4. 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

    Measured: One year

  5. 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).

    Measured: One year

  6. 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

    Measured: Two year

  7. Compare cardiovascular risk factors (hypertension) in Italian and Spanish university students

    Blood pressure will be recorded on the data collection form

    Measured: Two year

  8. 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.

    Measured: Two year

  9. 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)

    Measured: Two year

Secondary outcomes (17)
  1. Compare and evaluate the level of physical activity in Italian and Spanish university students

    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.

    Measured: One year

  2. Compare and evaluate the percentage of subjects with orthorexia nervosa in Italian and Spanish university students

    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.

    Measured: One year

  3. Compare the frequency of meals consumed outside home in Italian and Spanish university students

    Outcome Measure will be evaluated by online questionnaires

    Measured: One year

  4. Compare the type of meals consumed outside home in Italian and Spanish university students

    Outcome Measure will be evaluated by online questionnaires

    Measured: One year

  5. Compare the type of food/beverages consumed in Italian and Spanish university students

    Outcome Measure will be evaluated by online questionnaires

    Measured: One year

  6. Compare the consumption of food/beverages in Italian and Spanish university students

    Outcome Measure will be evaluated by online questionnaires

    Measured: One year

  7. Compare the adherence to special dietary regimes (vegetarian diet, ketogenic etc) in Italian and Spanish university students

    Outcome Measure will be evaluated by online questionnaires

    Measured: One year

  8. Register other characteristics of interest (pathologies)

    Other characeristics of interest will be evaluated by online questionnaires

    Measured: One year

  9. Register other characteristics of interest (anxiety/depressive symptoms)

    Other characeristics of interest will be evaluated by online questionnaires

    Measured: One year

  10. Register other characteristics of interest (food neophobia)

    Other characeristics of interest will be evaluated by online questionnaires

    Measured: One year

  11. Register other characteristics of interest (eating disorders)

    Other characeristics of interest will be evaluated by online questionnaires

    Measured: One year

  12. Register other characteristics of interest (vaccinations and opinion on vaccines)

    Other characeristics of interest will be evaluated by online questionnaires

    Measured: One year

  13. Compare eating habits in a sub-group of non-smoking Italian and Spanish students

    Eating habits will be evaluated by online questionnaires

    Measured: Two year

  14. Compare salivary microbiota in a sub-group of non-smoking Italian and Spanish students

    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.

    Measured: Two year

  15. Compare salivary IgA levels in a sub-group of non-smoking Italian and Spanish students

    Salivary IgA levels will be measured with ELISA kit

    Measured: Two year

  16. Compare salivary IL-6 levels in a sub-group of non-smoking Italian and Spanish students

    Salivary IL-6 levels will be measured with ELISA kit

    Measured: Two year

  17. Compare salivary cortisol levels in a sub-group of non-smoking Italian and Spanish students

    Salivary cortisol levels will be measured with ELISA kit

    Measured: Two year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start17 Jul 2019
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099420
Sponsor's protocol ID
1382/2019
Other IDs
CE071906
Acronym
STANIS
Status last verified
Nov 2020
First submitted
18 Aug 2019
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Medication Adherence, run by Maura Palmery at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paola Aiello, PhD student (3385733844 ext. +39, paola.aiello@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the prescription of drugs in Italian and Spanish university students (time frame: One year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in