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

European Institute of Oncology150 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Nutritional Deficiencies Quality of Life

Interventions

personalized nutritional counselingOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

European Institute of Oncology, Milan, Recruiting

Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

Survey on nutritional adequacy of participants' diet at 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.

Time frame: Baseline

Survey on dietary and lifestyle quality of participants at 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.

Time frame: Baseline

Secondary Outcomes

Nutrient Adequacy Ratio (NAR)

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

Time frame: 3-month

Mean Adequacy Ratio (MAR)

change in MAR calculated by averaging all NARs together

Time frame: 3-month

Vegetarian life style index (VLI)

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

Time frame: 3-month

Blood analysis- glucose

change in concentration of glucose (mg/dl)

Central Contacts

Patrizia Gnagnarella, PhD

CONTACT

+39 0257489823 patrizia.gnagnarella@ieo.it

Data from ClinicalTrials.gov

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