NCT06881745

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

August 6, 2024

Last Update Submit

March 11, 2025

Conditions

Keywords

Mediterranean DietPhysical ActivityAthletesNutritional statusNutrition knowledge

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (4)

  • Assessment of nutrition knowledge

    Baseline

  • Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised

    Baseline

  • Eating behaviour assessment

    Baseline

  • Eating behavior assessment

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia

Pavia, PV, 27100, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

Feeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Cinzia Ferraris, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Ferraris, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2024

First Posted

March 18, 2025

Study Start

July 5, 2024

Primary Completion

March 10, 2025

Study Completion

February 28, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations