Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)
9 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Geschat)
150
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Patrizia Gnagnarella, PhD
- Telefoonnummer: +39 0257489823
- E-mail: patrizia.gnagnarella@ieo.it
Studie Locaties
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Milan, Italië, 20141
- Werving
- European Institute of Oncology, Milan, Recruiting
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Contact:
- Patrizia Gnagnarella
- Telefoonnummer: +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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Survey on nutritional adequacy of participants' diet at baseline
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Nutrient Adequacy Ratio (NAR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3-month
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change in Body weight (kg)
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3-month
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Anthropometric measurements - circumferences
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Patrizia Gnagnarella, PhD, European Institute of Oncology
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 maart 2026
Primaire voltooiing (Geschat)
26 januari 2028
Studie voltooiing (Geschat)
26 januari 2028
Studieregistratiedata
Eerst ingediend
25 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
10 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2026
Laatst geverifieerd
1 februari 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UID 4909
- L2-476 (Andere identificatie: Comitato Etico Territoriale Lombardia 2)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .