Diet quality and nutrient adequacy in vegetarian and vegan women at a Milan cancer institute

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

150 vegan, vegetarian, or semi-vegetarian women aged 18–64 attending the European Institute of Oncology will receive baseline assessments of nutritional adequacy and diet quality, followed by three months of individualized nutritional counselling. The study tracks changes in body composition, physical activity, and quality of life while collecting anthropometric data, blood biomarkers, and dietary intake. Assessments occur at baseline and after three months, with an interim phone contact to support adherence. Nutritional adequacy will be evaluated against Italian dietary reference values and dietary guidelines for vegetarian patterns. This is an interventional, single-arm assessment of a diet-focused counseling approach in a cancer-relevant population with or without prior neoplasia.

Why it matters

Who can join: the full rules

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;

Where it's running

• European Institute of Oncology, Milan, Recruiting
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Patrizia Gnagnarella, PhD — European Institute of Oncology
• Study coordinator: Patrizia Gnagnarella, PhD
• Email: patrizia.gnagnarella@ieo.it
• Phone: +39 0257489823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.