Nutritional Deficiencies, Quality of Life
Conditions
Keywords
vegan, vegetarian, semivegetarian diet
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.
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).
Interventions
OTHERpersonalized nutritional counseling
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.
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survey on nutritional adequacy of participants' diet at baseline | 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. |
| Survey on dietary and lifestyle quality of participants at baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrient Adequacy Ratio (NAR) | 3-month | change in NAR calculated by dividing participant's intake of a given nutrient by the Italian DRVs for the corresponding age category |
| Mean Adequacy Ratio (MAR) | 3-month | change in MAR calculated by averaging all NARs together |
| Vegetarian life style index (VLI) | 3-month | change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence. |
| Blood analysis- glucose | 3-month | change in concentration of glucose (mg/dl) |
| Blood analysis- insulin | 3-month | change in concentration of insulin (mUI/L) |
| Blood analysis- total cholesterol | 3-month | change in concentration of total cholesterol (mg/dl) |
| Blood analysis-LDL cholesterol | 3-month | change in concentration of LDL cholesterol (mg/dl) |
| Blood analysis-HDL cholesterol | 3-month | change in concentration HDL cholesterol (mg/dl) |
| Blood analysis-triglycerides (mg/dl) | 3-month | change in concentration of triglycerides (mg/dl) |
| Blood analysis- vitamins-B6 | 3-month | change in concentration of B6(mcg/L) |
| Blood analysis- vitamins-B12 | 3-month | change in concentration of B12 (ng/L) |
| Blood analysis- vitamins-folate | 3-month | change in concentration of folate (mcg/L) |
| Blood analysis- vitamins-Vitamin D | 3-month | change in concentration of Vitamin D (mcg/L) |
| Blood analysis- iron status | 3-month | change in concentration of iron (mcg/dl) |
| Blood analysis- ferritin status | 3-month | change in concentration of ferritin (mcg/L) |
| Blood analysis- Calcium | 3-month | change in concentration of calcium (mg/dl) |
| Blood analysis- total protein | 3-month | change in concentration of total protein (g/dl) |
| Anthropometric measurements - Body weight | 3-month | change in Body weight (kg) |
| Anthropometric measurements - circumferences | 3-month | change in waist and hip circumferences (cm) |
| Anthropometric measurements - Body composition | 3-month | change in fat mass and fat free mass (kg) |
| Physical activity | 3-month | change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) |
| Quality of life (VEGQOL) | 3-month | change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL. |
| Adherence to the Mediterranean diet | 3-month | change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence |
Countries
Italy
Contacts
CONTACTPatrizia Gnagnarella, PhD
PRINCIPAL_INVESTIGATORPatrizia Gnagnarella, PhD
European Institute of Oncology
Outcome results
None listed