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

NCT07638839 | Recruiting

• 2 other identifiers: UID 4909L2-476
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutritional Deficiencies; Quality of Life

Keywords

vegan; vegetarian; semivegetarian diet

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (23)

• Nutrient Adequacy Ratio (NAR)

  3-month

• Mean Adequacy Ratio (MAR)

  3-month

• Vegetarian life style index (VLI)

  3-month

• Blood analysis- glucose

  3-month

• Blood analysis- insulin

  3-month

Study Arms (1)

vegetarian study population

EXPERIMENTAL

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)

Other: personalized nutritional counseling

Interventions

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.

vegetarian study population

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology, Milan, Recruiting

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Patrizia Gnagnarella, PhD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Gnagnarella, PhD

CONTACT

+39 0257489823; patrizia.gnagnarella@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: June 10, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): January 26, 2028
• Study Completion (Estimated): January 26, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)