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Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Andet: personalized nutritional counseling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survey on nutritional adequacy of participants' diet at baseline
Tidsramme: Baseline
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.
Baseline
Survey on dietary and lifestyle quality of participants at baseline
Tidsramme: Baseline
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.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nutrient Adequacy Ratio (NAR)
Tidsramme: 3-month
change in NAR calculated by dividing participant's intake of a given nutrient by the Italian DRVs for the corresponding age category
3-month
Mean Adequacy Ratio (MAR)
Tidsramme: 3-month
change in MAR calculated by averaging all NARs together
3-month
Vegetarian life style index (VLI)
Tidsramme: 3-month
change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.
3-month
Blood analysis- glucose
Tidsramme: 3-month
change in concentration of glucose (mg/dl)
3-month
Blood analysis- insulin
Tidsramme: 3-month
change in concentration of insulin (mUI/L)
3-month
Blood analysis- total cholesterol
Tidsramme: 3-month
change in concentration of total cholesterol (mg/dl)
3-month
Blood analysis-LDL cholesterol
Tidsramme: 3-month
change in concentration of LDL cholesterol (mg/dl)
3-month
Blood analysis-HDL cholesterol
Tidsramme: 3-month
change in concentration HDL cholesterol (mg/dl)
3-month
Blood analysis-triglycerides (mg/dl)
Tidsramme: 3-month
change in concentration of triglycerides (mg/dl)
3-month
Blood analysis- vitamins-B6
Tidsramme: 3-month
change in concentration of B6(mcg/L)
3-month
Blood analysis- vitamins-B12
Tidsramme: 3-month
change in concentration of B12 (ng/L)
3-month
Blood analysis- vitamins-folate
Tidsramme: 3-month
change in concentration of folate (mcg/L)
3-month
Blood analysis- vitamins-Vitamin D
Tidsramme: 3-month
change in concentration of Vitamin D (mcg/L)
3-month
Blood analysis- iron status
Tidsramme: 3-month
change in concentration of iron (mcg/dl)
3-month
Blood analysis- ferritin status
Tidsramme: 3-month
change in concentration of ferritin (mcg/L)
3-month
Blood analysis- Calcium
Tidsramme: 3-month
change in concentration of calcium (mg/dl)
3-month
Blood analysis- total protein
Tidsramme: 3-month
change in concentration of total protein (g/dl)
3-month
Anthropometric measurements - Body weight
Tidsramme: 3-month
change in Body weight (kg)
3-month
Anthropometric measurements - circumferences
Tidsramme: 3-month
change in waist and hip circumferences (cm)
3-month
Anthropometric measurements - Body composition
Tidsramme: 3-month
change in fat mass and fat free mass (kg)
3-month
Physical activity
Tidsramme: 3-month
change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf)
3-month
Quality of life (VEGQOL)
Tidsramme: 3-month
change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL.
3-month
Adherence to the Mediterranean diet
Tidsramme: 3-month
change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence
3-month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

European Institute of Oncology

Efterforskere

  • Ledende efterforsker: Patrizia Gnagnarella, PhD, European Institute of Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. marts 2026

Primær færdiggørelse (Anslået)

26. januar 2028

Studieafslutning (Anslået)

26. januar 2028

Datoer for studieregistrering

Først indsendt

25. marts 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UID 4909
  • L2-476 (Anden identifikator: Comitato Etico Territoriale Lombardia 2)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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