Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
personalized nutritional counseling
Other interventionParticipants 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: vegetarian study populationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline2
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
BaselineSecondary outcomes
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
Time frame
3-month2
Mean Adequacy Ratio (MAR)
change in MAR calculated by averaging all NARs together
Time frame
3-month3
Vegetarian life style index (VLI)
change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.
Time frame
3-month4
Blood analysis- glucose
change in concentration of glucose (mg/dl)
Time frame
3-monthSponsors and contacts
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Source ClinicalTrials.gov