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NCT Number: NCT07638839

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

personalized nutritional counseling

Other

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.

Primary outcomes

  1. Survey on nutritional adequacy of participants' diet at baseline

    Time frame: 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.

  2. Survey on dietary and lifestyle quality of participants at baseline

    Time frame: 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.

Secondary outcomes

  1. Nutrient Adequacy Ratio (NAR)

    Time frame: 3-month

    change in NAR calculated by dividing participant's intake of a given nutrient by the Italian DRVs for the corresponding age category

  2. Mean Adequacy Ratio (MAR)

    Time frame: 3-month

    change in MAR calculated by averaging all NARs together

  3. Vegetarian life style index (VLI)

    Time frame: 3-month

    change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.

  4. Blood analysis- glucose

    Time frame: 3-month

    change in concentration of glucose (mg/dl)

  5. Blood analysis- insulin

    Time frame: 3-month

    change in concentration of insulin (mUI/L)

  6. Blood analysis- total cholesterol

    Time frame: 3-month

    change in concentration of total cholesterol (mg/dl)

  7. Blood analysis-LDL cholesterol

    Time frame: 3-month

    change in concentration of LDL cholesterol (mg/dl)

  8. Blood analysis-HDL cholesterol

    Time frame: 3-month

    change in concentration HDL cholesterol (mg/dl)

  9. Blood analysis-triglycerides (mg/dl)

    Time frame: 3-month

    change in concentration of triglycerides (mg/dl)

  10. Blood analysis- vitamins-B6

    Time frame: 3-month

    change in concentration of B6(mcg/L)

  11. Blood analysis- vitamins-B12

    Time frame: 3-month

    change in concentration of B12 (ng/L)

  12. Blood analysis- vitamins-folate

    Time frame: 3-month

    change in concentration of folate (mcg/L)

  13. Blood analysis- vitamins-Vitamin D

    Time frame: 3-month

    change in concentration of Vitamin D (mcg/L)

  14. Blood analysis- iron status

    Time frame: 3-month

    change in concentration of iron (mcg/dl)

  15. Blood analysis- ferritin status

    Time frame: 3-month

    change in concentration of ferritin (mcg/L)

  16. Blood analysis- Calcium

    Time frame: 3-month

    change in concentration of calcium (mg/dl)

  17. Blood analysis- total protein

    Time frame: 3-month

    change in concentration of total protein (g/dl)

  18. Anthropometric measurements - Body weight

    Time frame: 3-month

    change in Body weight (kg)

  19. Anthropometric measurements - circumferences

    Time frame: 3-month

    change in waist and hip circumferences (cm)

  20. Anthropometric measurements - Body composition

    Time frame: 3-month

    change in fat mass and fat free mass (kg)

  21. Physical activity

    Time frame: 3-month

    change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf)

  22. Quality of life (VEGQOL)

    Time frame: 3-month

    change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL.

  23. Adherence to the Mediterranean diet

    Time frame: 3-month

    change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Gnagnarella, PhD

CONTACT

[email protected]

+39 0257489823

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Survey on Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology

Acronym: VEGETARIANS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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