Nutritional Status and Emotional Well-being of the Worker-consumer in the Food Supply Chain.

NCT06896877 | Completed

• 1 other identifier: FDG_BRIC_ONEHEALTH
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the well-being and safety of worker-consumers in the food industry, focusing on nutrition, musculoskeletal disorders, and regulatory policies. It follows a "OneHealth" approach, emphasizing the connection between human, animal, and environmental health. The research evaluates the nutritional status of workers in the food-supply chain, analyzing food consumption in both workplace and domestic settings to identify deficiencies or excesses. Through clinical, nutritional, and psychological assessments-including oxidative stress levels, serotonin, quality of life, and emotional well-being-the study seeks to identify high-risk groups and gender differences, providing data-driven insights for personalized dietary recommendations and targeted interventions. Findings will contribute to national policies for improved workforce well-being, supporting best practices and interventions to enhance health, safety, and productivity in the agri-food sector. The results will serve as the foundation for specific guidelines that strengthen the sector's sustainability and regulatory clarity.

Conditions

Healthy

Keywords

food supply chain worker; nutritional status; quality of life

Outcome Measures

Primary Outcomes (1)

• The difference in the bioimpedance vectors between two groups of patients (active workers versus sedentary workers), according to BIVA

  The difference in bioimpedance vectors between two groups of patients (active workers vs. sedentary workers) will be analyzed using Bioelectrical Impedance Vector Analysis (BIVA). In BIVA, the Resistance (Rz) and Reactance (Xc) of each subject, standardized by height (in meters), are plotted on an Rz-Xc graph, forming a bioimpedance vector that can be visualized and analyzed. Measurements will be obtained through Bioelectrical Impedance Analysis (BIA), providing raw data on Resistance (Rz) and Reactance (Xc), which reflect an individual's hydration status and body composition. The differences in bioimpedance vectors between the two groups (active vs. sedentary workers) will be assessed.

  baseline

Secondary Outcomes (38)

• Weight in kilograms

  baseline

• Height in meters

  baseline

• Body mass Index in kg/(m^2)

  baseline

• Waist circumferences expressed in cm

  baseline

• Hips circumferences expressed in cm

  baseline

Study Arms (1)

Healthy worker

Participants will be healthy worker of the food-supply chain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy workers of food-supply-chain

You may qualify if:

• workers affiliated with the Experimental Center, or indirectly connected to the Experimental Center as part of the food supply chain;
• willingness to undergo specific tests, including nutritional status assessments, quality of life surveys, and emotional-affective well-being evaluations;
• signature of informed consent form.

You may not qualify if:

• pregnancy: pregnant women will be excluded to prevent physiological changes related to pregnancy from affecting the measurements.
• non-representative special diets: workers following special diets for medical or religious reasons, which may not be representative of the general food supply chain population, will be excluded.
• lack of signed informed consent.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, RM, 00166, Italy

Location

Related Publications (8)

• Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.

  PMID: 9817120 BACKGROUND

• Di Vincenzo O, Marra M, Sammarco R, Speranza E, Cioffi I, Scalfi L. Body composition, segmental bioimpedance phase angle and muscular strength in professional volleyball players compared to a control group. J Sports Med Phys Fitness. 2020 Jun;60(6):870-874. doi: 10.23736/S0022-4707.20.10548-6.

  PMID: 32487981 BACKGROUND

• Liguori I, Russo G, Curcio F, Bulli G, Aran L, Della-Morte D, Gargiulo G, Testa G, Cacciatore F, Bonaduce D, Abete P. Oxidative stress, aging, and diseases. Clin Interv Aging. 2018 Apr 26;13:757-772. doi: 10.2147/CIA.S158513. eCollection 2018.

  PMID: 29731617 BACKGROUND

• Campa F, Silva AM, Matias CN, Monteiro CP, Paoli A, Nunes JP, Talluri J, Lukaski H, Toselli S. Body Water Content and Morphological Characteristics Modify Bioimpedance Vector Patterns in Volleyball, Soccer, and Rugby Players. Int J Environ Res Public Health. 2020 Sep 10;17(18):6604. doi: 10.3390/ijerph17186604.

  PMID: 32927903 BACKGROUND

• Sies H. Oxidative stress: a concept in redox biology and medicine. Redox Biol. 2015;4:180-3. doi: 10.1016/j.redox.2015.01.002. Epub 2015 Jan 3.

  PMID: 25588755 BACKGROUND

• Vassalle C, Vigna L, Bianchi S, Maffei S, Novembrino C, De Giuseppe R, de Liso F, Vannucci A, Tirelli S, Maiavacca R, Bamonti F. A biomarker of oxidative stress as a nontraditional risk factor in obese subjects. Biomark Med. 2013 Aug;7(4):633-9. doi: 10.2217/bmm.13.49.

  PMID: 23905900 BACKGROUND

• Silva AM. Structural and functional body components in athletic health and performance phenotypes. Eur J Clin Nutr. 2019 Feb;73(2):215-224. doi: 10.1038/s41430-018-0321-9. Epub 2018 Oct 4.

  PMID: 30287933 BACKGROUND

• Siotto M, Cocco C, Bertoncini C, Guerrini A, Habib V, Antonacci E, Ruco E, Aprile IG. One Health Approach to Nutritional Status and Well-Being in Food Supply Chain Workers: A Study Protocol. Int J Environ Res Public Health. 2026 Jan 11;23(1):99. doi: 10.3390/ijerph23010099.

  PMID: 41595893 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample will be collected from blood of participants

Study Officials

• Irene G Aprile, MD, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 26, 2025
• Study Start: June 20, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)