Clinical trial NCT06896877: Nutritional Status and Emotional Well-being of the Worker-consumer in the Food Supply Chain.
Official title: Assessment of the Nutritional Status and Emotional Well-being of the Worker-consumer in the Food Supply Chain.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy
Keywords: food supply chain worker
nutritional status
quality of life
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy workers of food-supply-chain

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.

Detailed 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: The difference in the bioimpedance vectors between two groups of patients (active workers versus sedentary workers), according to BIVA
timeFrame: baseline
Secondary outcomes:
measure: Weight in kilograms
timeFrame: baseline
measure: Height in meters
timeFrame: baseline
measure: Body mass Index in kg/(m^2)
timeFrame: baseline
measure: Waist circumferences expressed in cm
timeFrame: baseline
measure: Hips circumferences expressed in cm
timeFrame: baseline
measure: Waist-Hips Ratio (WHR)
timeFrame: baseline
measure: Arm circumferences expressed in cm
timeFrame: baseline
measure: Calf circumferences expressed in cm
timeFrame: baseline
measure: Tissue hydration expressed in percentage from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Nutritional index (mg 24h/height in meters) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Resistance (Rz) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Reactance (Xc) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Phase Angle (PhA) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Total Body Water (TBW) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Fat Free Mass (FFM) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Fat Mass (FM) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Body Cell Mass (BCM) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Skeletal Muscle Mass from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Appendicular Skeletal Muscle Mass (ASMM) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Basal metabolic rate (BMR) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Total Daily Energy Expenditure (TDEE) from Bioelectrical Impedance Analysis (BIA).
timeFrame: baseline
measure: Concentration of serum serotonin (ng/mL)
timeFrame: baseline
measure: Blood concentration of haemoglobin (g/dL)
timeFrame: baseline
measure: Blood levels of lymphocyte (cell per microliters or percentage)
timeFrame: baseline
measure: Concentration of serum albumin (g/dL)
timeFrame: baseline
measure: Concentration of serum total cholesterol (mg/dL)
timeFrame: baseline
measure: Concentration of HDL cholesterol serum levels (mg/dL)
timeFrame: baseline
measure: Concentration of C-reactive protein (mg/dL)
timeFrame: baseline
measure: Concentration of glucose serum levels (mg/dL)
timeFrame: baseline
measure: Concentration of triglycerides serum levels (mg/dL)
timeFrame: baseline
measure: Concentration of magnesium serum levels (mg/dL)
timeFrame: baseline
measure: Concentration of calcium serum levels in mg/dL
timeFrame: baseline
measure: Concentration of hydroperoxides serum levels (UCARR)
timeFrame: baseline
measure: Concentration of total antioxidant serum levels (µmol/L)
timeFrame: baseline
measure: Measurement of Oxidative stress Index (dimensionless ratio)
timeFrame: baseline
measure: Nutritional Risk Index NRI
timeFrame: baseline
measure: Prognostic Nutritional Index (PNI)
timeFrame: baseline
measure: Self-reported nutritional, psychological, and lifestyle survey
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Irene G Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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