Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)
9 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Estimé)
150
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Patrizia Gnagnarella, PhD
- Numéro de téléphone: +39 0257489823
- E-mail: patrizia.gnagnarella@ieo.it
Lieux d'étude
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Milan, Italie, 20141
- Recrutement
- European Institute of Oncology, Milan, Recruiting
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Contact:
- Patrizia Gnagnarella
- Numéro de téléphone: +39 0257489823
- E-mail: patrizia.gnagnarella@ieo.it
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Contact:
- Davide Serrano
- E-mail: davide.serrano@ieo.it
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Survey on nutritional adequacy of participants' diet at baseline
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Nutrient Adequacy Ratio (NAR)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 3-month
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change in Body weight (kg)
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3-month
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Anthropometric measurements - circumferences
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Patrizia Gnagnarella, PhD, European Institute of Oncology
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 mars 2026
Achèvement primaire (Estimé)
26 janvier 2028
Achèvement de l'étude (Estimé)
26 janvier 2028
Dates d'inscription aux études
Première soumission
25 mars 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juin 2026
Dernière vérification
1 février 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UID 4909
- L2-476 (Autre identifiant: Comitato Etico Territoriale Lombardia 2)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .