Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)
9 de junio de 2026 actualizado por: European Institute of Oncology
Survey on Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology
Despite their health benefits, vegetarian dietary patterns can lead to malnutrition and micronutrient deficiencies if improperly managed, especially in oncological settings.
This survey assesses dietary quality and adequacy in 150 women (18-64 years), further examining how a threemonth nutritional counseling intervention influences body composition, physical activity, and quality of life.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
150 vegan, vegetarian, semi-vegetarian women (18-64 years) will be recruited among patients attending the European Institute of Oncology for prevention visits or oncological follow-up. The study will include a baseline visit and a 3-month follow-up visit, with an interim telephone contact.
At baseline, nutritional adequacy and diet quality will be assessed, followed by a personalized nutritional counselling aimed at improving dietary variety, ensuring adequate nutrient intake, and promoting an active lifestyle. The intervention will be based on a vegetarian adaptation of the Healthy Eating Plate and aligned with national and international guidelines (CREA,2019; WCRF, 2018).
During study visits, anthropometric measurements (height, weight, waist and hip circumferences), body composition (BIVA), and blood samples will be collected. Dietary intake will be evaluated via a 3-day food records. Validated questionnaires will be administered to assess physical activity (IPAQ-SF), adherence to the Mediterranean diet (QueMD), and quality of life (VEGQOL). Additionally, vegetarian diet quality and lifestyle will be evaluated using the Vegetarian Lifestyle Index.
Nutritional adequacy will be determined by comparing dietary intake and blood biomarkers with Italian Dietary Reference Values (DRVs; SINU 2024).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Patrizia Gnagnarella, PhD
- Número de teléfono: +39 0257489823
- Correo electrónico: patrizia.gnagnarella@ieo.it
Ubicaciones de estudio
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Milan, Italia, 20141
- Reclutamiento
- European Institute of Oncology, Milan, Recruiting
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Contacto:
- Patrizia Gnagnarella
- Número de teléfono: +39 0257489823
- Correo electrónico: patrizia.gnagnarella@ieo.it
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Contacto:
- Davide Serrano
- Correo electrónico: davide.serrano@ieo.it
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- pre or post-menopausal women, aged between 18 and 64;
- healthy participants or high-risk cancer patients or patients with previous diagnosis of neoplasia
- self-identifying as vegan (defined as excluding all animal products), or vegetarian (defined as excluding all animal products besides eggs and/or dairy) or semi-vegetarian (defined as excluding no animal products but limiting meat to < 1× per week);
- ability to understand and the willingness to sign a written informed consent document;
Exclusion Criteria:
- any condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study (e.g., ulcerative colitis, Crohn's disease etc.);
- any diagnosis of invasive neoplasia, within the previous 1 years, except non-melanoma skin cancer;
- currently receiving chemotherapy, radiation, or immunotherapy as cancer treatment;
- patients dependent on enteral or parental nutrition;
- pregnancy or lactation;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: vegetarian study population
The study population comprises 150 women (18-64 years) adhering to plant-based diets (vegan, vegetarian, or semi-vegetarian), including both healthy individuals and those with a history or high risk of cancer recruited at the European Institute of Oncology (Milan, IT)
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Participants will receive personalized nutritional counseling by registered dietitians based on blood tests and 3-day food records, focusing on improving diet variety and optimizing intake of critical nutrients.
Additionally, lifestyle advice will be provided to increase physical activity and reduce sedentary behavior.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Survey on nutritional adequacy of participants' diet at baseline
Periodo de tiempo: Baseline
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Nutritional adequacy evaluated through blood biomarkers and dietary intake, assessed via 3-day food records.
Nutrient data will be referenced against the Italian Dietary Reference Values (DRVs).
Nutritional adequacy will be quantified by calculating the Nutrient Adequacy Ratio (NAR) and the Mean Adequacy Ratio (MAR).
The NAR represents the ratio of an individual's nutrient intake to the corresponding Italian DRV for their age group, while the MAR is the average of all calculated NARs.
Both indices will be expressed on a scale from 0 to 1, where 0 indicates that nutrient requirements are not met and 1 indicates that they are fully met.
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Baseline
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Survey on dietary and lifestyle quality of participants at baseline
Periodo de tiempo: Baseline
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A modified version of the vegetarian Lifestyle index is adapted to Italian guidelines and national recommendations.
The score comprises 11 dietary and 3 lifestyle components and ranges from 0 to 14, with higher score indicating greater adherence.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nutrient Adequacy Ratio (NAR)
Periodo de tiempo: 3-month
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change in NAR calculated by dividing participant's intake of a given nutrient by the Italian DRVs for the corresponding age category
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3-month
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Mean Adequacy Ratio (MAR)
Periodo de tiempo: 3-month
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change in MAR calculated by averaging all NARs together
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3-month
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Vegetarian life style index (VLI)
Periodo de tiempo: 3-month
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change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.
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3-month
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Blood analysis- glucose
Periodo de tiempo: 3-month
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change in concentration of glucose (mg/dl)
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3-month
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Blood analysis- insulin
Periodo de tiempo: 3-month
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change in concentration of insulin (mUI/L)
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3-month
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Blood analysis- total cholesterol
Periodo de tiempo: 3-month
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change in concentration of total cholesterol (mg/dl)
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3-month
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Blood analysis-LDL cholesterol
Periodo de tiempo: 3-month
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change in concentration of LDL cholesterol (mg/dl)
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3-month
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Blood analysis-HDL cholesterol
Periodo de tiempo: 3-month
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change in concentration HDL cholesterol (mg/dl)
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3-month
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Blood analysis-triglycerides (mg/dl)
Periodo de tiempo: 3-month
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change in concentration of triglycerides (mg/dl)
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3-month
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Blood analysis- vitamins-B6
Periodo de tiempo: 3-month
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change in concentration of B6(mcg/L)
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3-month
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Blood analysis- vitamins-B12
Periodo de tiempo: 3-month
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change in concentration of B12 (ng/L)
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3-month
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Blood analysis- vitamins-folate
Periodo de tiempo: 3-month
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change in concentration of folate (mcg/L)
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3-month
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Blood analysis- vitamins-Vitamin D
Periodo de tiempo: 3-month
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change in concentration of Vitamin D (mcg/L)
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3-month
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Blood analysis- iron status
Periodo de tiempo: 3-month
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change in concentration of iron (mcg/dl)
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3-month
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Blood analysis- ferritin status
Periodo de tiempo: 3-month
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change in concentration of ferritin (mcg/L)
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3-month
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Blood analysis- Calcium
Periodo de tiempo: 3-month
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change in concentration of calcium (mg/dl)
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3-month
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Blood analysis- total protein
Periodo de tiempo: 3-month
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change in concentration of total protein (g/dl)
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3-month
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Anthropometric measurements - Body weight
Periodo de tiempo: 3-month
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change in Body weight (kg)
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3-month
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Anthropometric measurements - circumferences
Periodo de tiempo: 3-month
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change in waist and hip circumferences (cm)
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3-month
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Anthropometric measurements - Body composition
Periodo de tiempo: 3-month
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change in fat mass and fat free mass (kg)
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3-month
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Physical activity
Periodo de tiempo: 3-month
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change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf)
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3-month
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Quality of life (VEGQOL)
Periodo de tiempo: 3-month
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change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL.
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3-month
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Adherence to the Mediterranean diet
Periodo de tiempo: 3-month
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change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence
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3-month
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Patrizia Gnagnarella, PhD, European Institute of Oncology
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de marzo de 2026
Finalización primaria (Estimado)
26 de enero de 2028
Finalización del estudio (Estimado)
26 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
25 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de febrero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UID 4909
- L2-476 (Otro identificador: Comitato Etico Territoriale Lombardia 2)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .