Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: personalized nutritional counseling.
- Who it may be relevant to
- Registry conditions: Nutritional Deficiencies, Quality of Life. Basic parameters: 18 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Survey on Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology
Overview
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.
Detailed description
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).
Interventions
- Other 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.
Primary outcome measures
- Survey on nutritional adequacy of participants' diet at baseline [Time frame: Baseline]
- Survey on dietary and lifestyle quality of participants at baseline [Time frame: Baseline]
Secondary outcome measures (12)
- Nutrient Adequacy Ratio (NAR) [Time frame: 3-month]
- Mean Adequacy Ratio (MAR) [Time frame: 3-month]
- Vegetarian life style index (VLI) [Time frame: 3-month]
- Blood analysis- glucose [Time frame: 3-month]
- Blood analysis- insulin [Time frame: 3-month]
- Blood analysis- total cholesterol [Time frame: 3-month]
- Blood analysis-LDL cholesterol [Time frame: 3-month]
- Blood analysis-HDL cholesterol [Time frame: 3-month]
- Blood analysis-triglycerides (mg/dl) [Time frame: 3-month]
- Blood analysis- vitamins-B6 [Time frame: 3-month]
- Blood analysis- vitamins-B12 [Time frame: 3-month]
- Blood analysis- vitamins-folate [Time frame: 3-month]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- European Institute of Oncology, Milan, Recruiting — Milan
Identifiers
NCT: NCT07638839 · UID 4909 · L2-476