European Institute of Oncology, Milan, Recruiting
Milan, 20141, Italy
Location status: Recruiting
Location contact
Davide Serrano
CONTACT
Patrizia Gnagnarella
CONTACT
NCT Number: NCT07638839
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.
Interested in participating?
Request Info18 year–64 year
Female
Interventional
Not applicable
Milan, 20141, Italy
Location status: Recruiting
Davide Serrano
CONTACT
Patrizia Gnagnarella
CONTACT
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
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: 3-month
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
change in MAR calculated by averaging all NARs together
Time frame: 3-month
change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.
Time frame: 3-month
change in concentration of glucose (mg/dl)
Time frame: 3-month
change in concentration of insulin (mUI/L)
Time frame: 3-month
change in concentration of total cholesterol (mg/dl)
Time frame: 3-month
change in concentration of LDL cholesterol (mg/dl)
Time frame: 3-month
change in concentration HDL cholesterol (mg/dl)
Time frame: 3-month
change in concentration of triglycerides (mg/dl)
Time frame: 3-month
change in concentration of B6(mcg/L)
Time frame: 3-month
change in concentration of B12 (ng/L)
Time frame: 3-month
change in concentration of folate (mcg/L)
Time frame: 3-month
change in concentration of Vitamin D (mcg/L)
Time frame: 3-month
change in concentration of iron (mcg/dl)
Time frame: 3-month
change in concentration of ferritin (mcg/L)
Time frame: 3-month
change in concentration of calcium (mg/dl)
Time frame: 3-month
change in concentration of total protein (g/dl)
Time frame: 3-month
change in Body weight (kg)
Time frame: 3-month
change in waist and hip circumferences (cm)
Time frame: 3-month
change in fat mass and fat free mass (kg)
Time frame: 3-month
change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf)
Time frame: 3-month
change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL.
Time frame: 3-month
change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence
Contact information is provided by the study sponsor or research team.
European Institute of Oncology
Other
Survey on Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology
Acronym: VEGETARIANS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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