Dietary HabitsNUTRI_ACTIVENCT06881745
Lifestyle and Nutrition Evaluation in Physically Active People and Athletes
An observational study of Dietary Habits and Nutritional Status, run by University of Pavia at 1 site in Italy.
Trial summary
The goal of this observational study is to explore the dietary intake, nutrition knowledge and body composition in Italian athletes and physically active adults. This is a nonprofit study aimed at improving clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Nutritional Status, Body Composition
- How many people
- 181 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jul 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample will be composed of volunteers from Pavia city, territorial sport centres, amateur sport clubs and National Sport Federations. The participants will be recruited at the Laboratory of Nutrition Education and Sport Nutrition at University of Pavia who agree to participate in the study and have signed the relevant informed consent.
Who may be able to join
- Age: ≥ 18 years old and ≤ 65 years old
- Regular physical activity (at least 150 minutes of moderate-intensity aerobic physical activity; or at least 75 of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week)
- All genders
Who cannot join
- Sedentary population: < 150 minutes of moderate-intensity aerobic physical activity or < 75 minutes of vigorous-intensity aerobic physical activity throughout the week
- Age: < 18 years old and > 65 years old
- Presence of diseases (i.e. diabetes, hypertension, dyslipidemia, metabolic syndrome, neurological diseases,…) and/or injuries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia
Pavia, PV, 27100
Cinzia Ferraris, PhD, 0382987868, cinzia.ferraris@unipv.it
About this study
Official title: NUTRI_ACTIVE Study: Lifestyle and Nutrition Evaluation in Physically Active People and Athletes
The goal of this observational study is to explore the dietary intake, nutrition knowledge and body composition in Italian athletes and physically active adults. This is a nonprofit study aimed at improving clinical practice. The main questions it aims to answer are:
- Assessment of level of adherence to Mediterranean Diet using MEDI-LITE questionnaire
- Assessment of nutrition knowledge
- Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised
- Eating behaviour assessment
Participants will undergo the following assessments: anthropometric and body composition assessments, Resting Metabolic Rate measurement, Dietary intake assessment, Nutrition knowledge, Lifestyle and behaviour, Physical activity assessment.
Read the detailed description
Participants will undergo the following assessments:
- Baseline assessment Nutrition assessment will be performed at the Laboratory of Nutrition Education and Sports Nutrition of the Department of Public Health, Experimental and Forensic Medicine at the University of Pavia.
The preliminary classification of the participants includes an evaluation of the inclusion and exclusion criteria of the study. The participants will be classified according to the type of sport practised (team sports, endurance/long distance, middle distance/power, speed/strength, precision, racquet sports, combat/weight-making). Professionals from the research team involved in the research project will carry out this selection and classification.
All variables will be reported at study baseline. Preliminar general information will be collected (age, gender, educational level, occupation, lifestyle, weight history, nutrition intervention in the past…).
All participants will be fully evaluated by a trained team using the standardised procedure:
- weight, height measurement
- waist, hip, arm circumference
- skinfold thickness at the biceps, triceps, subscapular, suprailiac, abdominal, pectoral, mid-axillary, thigh sites
Body composition evaluation using the Bioelectrical Impedance Analysis, which is a non-invasive and commonly used method for assessing body composition (BIA 101 BIVA PROTM- AKERN). It works by passing a low-level electrical current through the body and measuring the resistance encountered by the current. Body tissues with different compositions (such as muscle, fat, and bone) conduct electricity differently, allowing BIA to estimate the proportion of lean body mass and body fat.
Resting Metabolic Rate measurement will be done with Indirect calorimetry that is the gold standard method to assess the Resting Metabolic Rate (RMR). This instrument will be used to measure RMR in the morning, in a fasted, rested state. The indirect calorimetry method requires the subject to wear a mask connected with a respiratory gas analyser. The duration of the test is about 30 minutes. There are no risks for the patient carrying out this test.
Dietary intake of this sample will be evaluated with a food frequency questionnaire (FFQ) composed of 110 items elaborated by Marventano and colleagues in 2016. The food items on the FFQ are grouped according to their nutrient contents in eight food groups, as follows: (a) Meat and fish products; (b) Sweets, nuts and snacks; (c) Vegetables; (d) Fruits; (e) Drinks; (f) Cereals and starchy foods; (g) Milk and dairy products; and (h) Oils and seasonings.
Participants will also complete a 7-day food diary. It records the type and quantity of food and beverages, time and place of consumption, psychological states and social events that interfere in the eating process. Supplement use will also be registered.
Data from the FFQ and food diary will be compared with each participant's nutritional requirements based on measurement of basal metabolic rate by indirect calorimetry adjusted for physical activity level.
Nutrition knowledge will be evaluated with the General and Sport Nutrition Knowledge questionnaire (GeSNK) that is composed by 62 items divided into two main areas which are respectively related to:
- Nutrition Knowledge in general (29 items)
- Sports Nutrition Knowledge (33 items)
Adherence to Mediterranean Diet will be evaluated with a specific tool: Mediterranean Diet Score (MEDI-LITE). The Medi-Lite adherence score consists of 9 items that assess the daily consumption of fruit, vegetables, cereals, meat and meat products, dairy products, alcohol, and olive oil, and the weekly consumption of legumes and fish. For each food group, there are three categories of consumption, based on data available in the literature in relation to adherence to the Mediterranean diet and health status. The final score is obtained from the sum of all these scores, and it ranges from 0 (low adherence) to 18 (high adherence).
Teruel Orthorexia Scale (TOS) will be also administered to participants. It is validated in Italy. It is a 17-item self-report measure articulated in 2 subscales: healthy orthorexia (9 items), which indicates a healthy, nonpathological interest in proper nutrition, and orthorexia nervosa (8 items), which represents an extreme preoccupation with healthy diet that may lead to relevant emotional, social, and cognitive impairments. All items are rated on a 4-point Likert scale, ranging from 0 (completely disagree) to 3 (completely agree).
Eating Attitude Test (EAT-26): it is the most widely used test to measure the symptoms and concerns characteristic of eating disorders. Scores greater than 20 indicate a need for further investigation by a qualified professional. Low scores (below 20) can still be consistent with serious eating problems, as denial of symptoms can be a problem with eating disorders. Results should be interpreted along with weight history, current BMI (body mass index), and percentage of Ideal Body Weight.
Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
International Physical Activity Questionnaires (IPAQ) - long form will also be administered to the participants. IPAQ was developed in the late 1990s as an instrument for cross-national assessment of duration and frequency of physical activity in the last seven days. This questionnaire analyses five domains: a) job-related activity; b) transportation; c) housework, house maintenance, caring for family d) recreation, sport and leisure time e) time spent sitting. This tool can be useful for the general lifestyle assessment.
- Conditions
- Dietary Habits, Nutritional Status, Body Composition, Athlete
- Keywords
- Mediterranean Diet, Physical Activity, Athletes, Nutritional status, Nutrition knowledge
- Medical subject headings
- Feeding Behavior, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of level of adherence to Mediterranean Diet
Adherence to Mediterranean Diet will be evaluated with Mediterranean Diet Score (MEDI-LITE). that consists of 9 items that assess the daily consumption of fruit, vegetables, cereals, meat and meat products, dairy products, alcohol, and olive oil, and the weekly consumption of legumes and fish. For each food group, there are three categories of consumption, based on data available in the literature in relation to adherence to the Mediterranean diet and health status. The final score is obtained from the sum of all these scores, and it ranges from 0 (low adherence) to 18 (high adherence).
Measured: Baseline
Secondary outcomes (4)
Assessment of nutrition knowledge
Nutrition knowledge will be evaluated with the General and Sport Nutrition Knowledge questionnaire (GeSNK) that is composed by 62 items divided into two main areas which are respectively related to:
Nutrition Knowledge in general (29 items) Sports Nutrition Knowledge (33 items)
Measured: Baseline
Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised
Dietary intake will be evaluated with a food frequency questionnaire (FFQ) composed of 110 items. The food items on the FFQ are grouped according to their nutrient contents in eight food groups, as follows: (a) Meat and fish products; (b) Sweets, nuts and snacks; (c) Vegetables; (d) Fruits; (e) Drinks; (f) Cereals and starchy foods; (g) Milk and dairy products; and (h) Oils and seasonings.
Participants will also complete a 7-day food diary. It records the type and quantity of food and beverages, time and place of consumption, psychological states and social events that interfere in the eating process. Supplement use will also be registered.
Data from the FFQ and food diary will be compared with each participant's nutritional requirements based on measurement of basal metabolic rate by indirect calorimetry adjusted for physical activity level.
Measured: Baseline
Eating behaviour assessment
Eating behavior will be assessed with two principle questionnaires:
Teruel Orthorexia Scale (TOS), a 17-item self-report measure articulated in 2 subscales: healthy orthorexia (9 items), which indicates a healthy, nonpathological interest in proper nutrition, and orthorexia nervosa (8 items), which represents an extreme preoccupation with healthy diet that may lead to relevant emotional, social, and cognitive impairments. All items are rated on a 4-point Likert scale, ranging from 0 (completely disagree) to 3 (completely agree).
Measured: Baseline
Eating behavior assessment
Eating Attitude Test (EAT-26) will be used to measure the symptoms and concerns characteristic of eating disorders. Scores greater than 20 indicate a need for further investigation by a qualified professional. Scores below 20 can still be consistent with serious eating problems, as denial of symptoms can be a problem with eating disorders.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start5 Jul 2024
- Primary completion10 Mar 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Cinzia Ferraris, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881745
- Sponsor's protocol ID
- 65268/2023
- Acronym
- NUTRI_ACTIVE
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRI_ACTIVE Study: Lifestyle and Nutrition Evaluation in Physically Active People and Athletes
- ClinicalTrials.gov ID
- NCT06881745
- Acronym / sponsor ID
- NUTRI_ACTIVE / 65268/2023
- Conditions
- Dietary Habits, Nutritional Status, Body Composition, Athlete
- Keywords
- Mediterranean Diet, Physical Activity, Athletes, Nutritional status, Nutrition knowledge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to explore the dietary intake, nutrition knowledge and body composition in Italian athletes and physically active adults. This is a nonprofit study aimed at improving clinical practice. The main questions it aims to answer are:
- Assessment of level of adherence to Mediterranean Diet using MEDI-LITE questionnaire
- Assessment of nutrition knowledge
- Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised
- Eating behaviour assessment
Participants will undergo the following assessments: anthropometric and body composition assessments, Resting Metabolic Rate measurement, Dietary intake assessment, Nutrition knowledge, Lifestyle and behaviour, Physical activity assessment.
Detailed description
Participants will undergo the following assessments:
- Baseline assessment Nutrition assessment will be performed at the Laboratory of Nutrition Education and Sports Nutrition of the Department of Public Health, Experimental and Forensic Medicine at the University of Pavia.
The preliminary classification of the participants includes an evaluation of the inclusion and exclusion criteria of the study. The participants will be classified according to the type of sport practised (team sports, endurance/long distance, middle distance/power, speed/strength, precision, racquet sports, combat/weight-making). Professionals from the research team involved in the research project will carry out this selection and classification.
All variables will be reported at study baseline. Preliminar general information will be collected (age, gender, educational level, occupation, lifestyle, weight history, nutrition intervention in the past…).
All participants will be fully evaluated by a trained team using the standardised procedure:
- weight, height measurement
- waist, hip, arm circumference
- skinfold thickness at the biceps, triceps, subscapular, suprailiac, abdominal, pectoral, mid-axillary, thigh sites
Body composition evaluation using the Bioelectrical Impedance Analysis, which is a non-invasive and commonly used method for assessing body composition (BIA 101 BIVA PROTM- AKERN). It works by passing a low-level electrical current through the body and measuring the resistance encountered by the current. Body tissues with different compositions (such as muscle, fat, and bone) conduct electricity differently, allowing BIA to estimate the proportion of lean body mass and body fat.
Resting Metabolic Rate measurement will be done with Indirect calorimetry that is the gold standard method to assess the Resting Metabolic Rate (RMR). This instrument will be used to measure RMR in the morning, in a fasted, rested state. The indirect calorimetry method requires the subject to wear a mask connected with a respiratory gas analyser. The duration of the test is about 30 minutes. There are no risks for the patient carrying out this test.
Dietary intake of this sample will be evaluated with a food frequency questionnaire (FFQ) composed of 110 items elaborated by Marventano and colleagues in 2016. The food items on the FFQ are grouped according to their nutrient contents in eight food groups, as follows: (a) Meat and fish products; (b) Sweets, nuts and snacks; (c) Vegetables; (d) Fruits; (e) Drinks; (f) Cereals and starchy foods; (g) Milk and dairy products; and (h) Oils and seasonings.
Participants will also complete a 7-day food diary. It records the type and quantity of food and beverages, time and place of consumption, psychological states and social events that interfere in the eating process. Supplement use will also be registered.
Data from the FFQ and food diary will be compared with each participant's nutritional requirements based on measurement of basal metabolic rate by indirect calorimetry adjusted for physical activity level.
Nutrition knowledge will be evaluated with the General and Sport Nutrition Knowledge questionnaire (GeSNK) that is composed by 62 items divided into two main areas which are respectively related to:
- Nutrition Knowledge in general (29 items)
- Sports Nutrition Knowledge (33 items)
Adherence to Mediterranean Diet will be evaluated with a specific tool: Mediterranean Diet Score (MEDI-LITE). The Medi-Lite adherence score consists of 9 items that assess the daily consumption of fruit, vegetables, cereals, meat and meat products, dairy products, alcohol, and olive oil, and the weekly consumption of legumes and fish. For each food group, there are three categories of consumption, based on data available in the literature in relation to adherence to the Mediterranean diet and health status. The final score is obtained from the sum of all these scores, and it ranges from 0 (low adherence) to 18 (high adherence).
Teruel Orthorexia Scale (TOS) will be also administered to participants. It is validated in Italy. It is a 17-item self-report measure articulated in 2 subscales: healthy orthorexia (9 items), which indicates a healthy, nonpathological interest in proper nutrition, and orthorexia nervosa (8 items), which represents an extreme preoccupation with healthy diet that may lead to relevant emotional, social, and cognitive impairments. All items are rated on a 4-point Likert scale, ranging from 0 (completely disagree) to 3 (completely agree).
Eating Attitude Test (EAT-26): it is the most widely used test to measure the symptoms and concerns characteristic of eating disorders. Scores greater than 20 indicate a need for further investigation by a qualified professional. Low scores (below 20) can still be consistent with serious eating problems, as denial of symptoms can be a problem with eating disorders. Results should be interpreted along with weight history, current BMI (body mass index), and percentage of Ideal Body Weight.
Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
International Physical Activity Questionnaires (IPAQ) - long form will also be administered to the participants. IPAQ was developed in the late 1990s as an instrument for cross-national assessment of duration and frequency of physical activity in the last seven days. This questionnaire analyses five domains: a) job-related activity; b) transportation; c) housework, house maintenance, caring for family d) recreation, sport and leisure time e) time spent sitting. This tool can be useful for the general lifestyle assessment.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will be composed of volunteers from Pavia city, territorial sport centres, amateur sport clubs and National Sport Federations. The participants will be recruited at the Laboratory of Nutrition Education and Sport Nutrition at University of Pavia who agree to participate in the study and have signed the relevant informed consent.
Key inclusion criteria (3 listed)
- Age: ≥ 18 years old and ≤ 65 years old
- Regular physical activity (at least 150 minutes of moderate-intensity aerobic physical activity; or at least 75 of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week)
- All genders
Key exclusion criteria (3 listed)
- Sedentary population: < 150 minutes of moderate-intensity aerobic physical activity or < 75 minutes of vigorous-intensity aerobic physical activity throughout the week
- Age: < 18 years old and > 65 years old
- Presence of diseases (i.e. diabetes, hypertension, dyslipidemia, metabolic syndrome, neurological diseases,…) and/or injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of level of adherence to Mediterranean Diet
Time frame: Baseline
Adherence to Mediterranean Diet will be evaluated with Mediterranean Diet Score (MEDI-LITE). that consists of 9 items that assess the daily consumption of fruit, vegetables, cereals, meat and meat products, dairy products, alcohol, and olive oil, and the weekly consumption of legumes and fish. For each food group, there are three categories of consumption, based on data available in the literature in relation to adherence to the Mediterranean diet and health status. The final score is obtained from the sum of all these scores, and it ranges from 0 (low adherence) to 18 (high adherence).
4 secondary outcomes
Assessment of nutrition knowledge
Time frame: Baseline
Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised
Time frame: Baseline
Eating behaviour assessment
Time frame: Baseline
Eating behavior assessment
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- web site of Laboratory of Food Education and Sport NutritionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cinzia Ferraris, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits and Nutritional Status, run by University of Pavia at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cinzia Ferraris, PhD (+39 0382987869, cinzia.ferraris@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of level of adherence to Mediterranean Diet (time frame: Baseline). 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 18 Mar 2025.