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

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT06896877

FDG_BRIC_ONEHEALTH

Details and patient eligibility

About

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.

Full description

The study aims to assess, key health parameters in worker-consumers within the food-supply chain. The assessment will be performed during a single visit, assessing:

1. the nutritional status of workers: measuring participants' nutritional status to identify potential deficiencies or excesses.
2. biological parameters involved in stress: i) the systemic oxidative stress and serotonin levels to evaluate the potential imbalance between pro-oxidant and antioxidant; ii) the serotonin serum levels to analyze the circadian rhythm regulation and satiety perception.
3. the quality of life and emotional well-being: using online surveys and validated clinical assessment scales, the study will determine participants' quality of life, with a focus on psychological, physical, and social factors, aiming to identify potential work-related challenges in the food-supply chain.

Secondary Objectives Identification of risk groups: based on nutritional assessments and oxidative stress levels, identifying worker groups at higher risk of developing health conditions due to poor dietary habits or exposure to stress factors.

Analysis of gender differences: Investigating potential gender-based variations in nutritional status, oxidative stress levels, and quality of life, to determine whether specific dietary or health recommendations are needed for men and women.

This study is designed as an exploratory investigation aimed at comparing two groups of individuals with distinct dietary habits and lifestyle patterns, particularly focusing on sedentary workers versus non-sedentary workers engaged in physically demanding tasks.

The number of worker enrolled will be 40 (20 sedentary workers vs 20 non sedentary workers). The sample size has been determined based on existing literature evidence, utilizing phase angle (Di Vincenzo, 2011) and bioelectrical impedance vector analysis (BIVA) (Campa, 2020) as key reference parameters. Statistical power analysis was conducted using G*Power (v.3.1.9.7), employing a two-tailed independent samples t-test, with a significance level (α) set at 0.05 and 80% statistical power.

Effect size estimates (Cohen's d) were as follows: Fat Mass (FM): 0.81 (estimated power 70.1% with 20 participants per group), Fat-Free Mass (FFM): 1.30 (power >95% with 20 participants per group), BIVA Vector Length (VL): 2.06 (power 80% with only 5 participants per group). The selected sample size is sufficient to detect significant differences in FFM and VL, while for FM, the statistical power remains slightly below 80%.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

40 participants in 1 patient group

Healthy worker

Description:

Participants will be healthy worker of the food-supply chain