AzTrials
AzTrials

Nutritional DeficienciesVEGETARIANSNCT07638839

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

A study testing personalized nutritional counseling in people with Nutritional Deficiencies and Quality of Life, run by European Institute of Oncology at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for
Nutritional Deficiencies, Quality of Life
What is being tested?
personalized nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
26 Mar 2026to 26 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patrizia Gnagnarella, PhD contact

+39 0257489823

patrizia.gnagnarella@ieo.it

Italy1 site, 1 recruiting

  • European Institute of Oncology, Milan, Recruiting

    Milan, 20141

    Patrizia Gnagnarella, +39 0257489823, patrizia.gnagnarella@ieo.it

    Davide Serrano, davide.serrano@ieo.it

    Recruiting

Other trials in Italy

About this study

Official title: Survey on 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.

Read the 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).

Being tested
personalized nutritional counseling
Keywords
vegan, vegetarian, semivegetarian diet
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07638839
Study groupRoleWhat they receive
vegetarian study populationExperimentalThe 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)
Receives: Other: personalized nutritional counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

Secondary outcomes (23)

  1. 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

    Measured: 3-month

  2. Mean Adequacy Ratio (MAR)

    change in MAR calculated by averaging all NARs together

    Measured: 3-month

  3. Vegetarian life style index (VLI)

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

    Measured: 3-month

  4. Blood analysis- glucose

    change in concentration of glucose (mg/dl)

    Measured: 3-month

  5. Blood analysis- insulin

    change in concentration of insulin (mUI/L)

    Measured: 3-month

  6. Blood analysis- total cholesterol

    change in concentration of total cholesterol (mg/dl)

    Measured: 3-month

  7. Blood analysis-LDL cholesterol

    change in concentration of LDL cholesterol (mg/dl)

    Measured: 3-month

  8. Blood analysis-HDL cholesterol

    change in concentration HDL cholesterol (mg/dl)

    Measured: 3-month

  9. Blood analysis-triglycerides (mg/dl)

    change in concentration of triglycerides (mg/dl)

    Measured: 3-month

  10. Blood analysis- vitamins-B6

    change in concentration of B6(mcg/L)

    Measured: 3-month

  11. Blood analysis- vitamins-B12

    change in concentration of B12 (ng/L)

    Measured: 3-month

  12. Blood analysis- vitamins-folate

    change in concentration of folate (mcg/L)

    Measured: 3-month

  13. Blood analysis- vitamins-Vitamin D

    change in concentration of Vitamin D (mcg/L)

    Measured: 3-month

  14. Blood analysis- iron status

    change in concentration of iron (mcg/dl)

    Measured: 3-month

  15. Blood analysis- ferritin status

    change in concentration of ferritin (mcg/L)

    Measured: 3-month

  16. Blood analysis- Calcium

    change in concentration of calcium (mg/dl)

    Measured: 3-month

  17. Blood analysis- total protein

    change in concentration of total protein (g/dl)

    Measured: 3-month

  18. Anthropometric measurements - Body weight

    change in Body weight (kg)

    Measured: 3-month

  19. Anthropometric measurements - circumferences

    change in waist and hip circumferences (cm)

    Measured: 3-month

  20. Anthropometric measurements - Body composition

    change in fat mass and fat free mass (kg)

    Measured: 3-month

  21. Physical activity

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

    Measured: 3-month

  22. Quality of life (VEGQOL)

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

    Measured: 3-month

  23. Adherence to the Mediterranean diet

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

    Measured: 3-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start26 Mar 2026
  3. Primary completion26 Jan 2028 (estimated)
  4. Study completion26 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638839
Sponsor's protocol ID
UID 4909
Other IDs
L2-476
Acronym
VEGETARIANS
Status last verified
Feb 2026
First submitted
25 Mar 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing personalized nutritional counseling in people with Nutritional Deficiencies and Quality of Life, run by European Institute of Oncology at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrizia Gnagnarella, PhD (+39 0257489823, patrizia.gnagnarella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survey on nutritional adequacy of participants' diet at baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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