Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)
9. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
150
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Patrizia Gnagnarella, PhD
- Telefonnummer: +39 0257489823
- E-post: patrizia.gnagnarella@ieo.it
Studiesteder
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Milan, Italia, 20141
- Rekruttering
- European Institute of Oncology, Milan, Recruiting
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Ta kontakt med:
- Patrizia Gnagnarella
- Telefonnummer: +39 0257489823
- E-post: patrizia.gnagnarella@ieo.it
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Ta kontakt med:
- Davide Serrano
- E-post: davide.serrano@ieo.it
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Survey on nutritional adequacy of participants' diet at baseline
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Nutrient Adequacy Ratio (NAR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3-month
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change in Body weight (kg)
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3-month
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Anthropometric measurements - circumferences
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patrizia Gnagnarella, PhD, European Institute of Oncology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. mars 2026
Primær fullføring (Antatt)
26. januar 2028
Studiet fullført (Antatt)
26. januar 2028
Datoer for studieregistrering
Først innsendt
25. mars 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. februar 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UID 4909
- L2-476 (Annen identifikator: Comitato Etico Territoriale Lombardia 2)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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