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Идёт набор NCT07638839

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

Без фазы С лечением Nutritional Deficiencies Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: personalized nutritional counseling.
Кому может быть актуально
Состояния в реестре: Nutritional Deficiencies, Quality of Life. Базовые параметры: 18 лет — 64 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Другое personalized 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.

Первичные конечные точки

  • Survey on nutritional adequacy of participants' diet at baseline [Срок оценки: Baseline]
  • Survey on dietary and lifestyle quality of participants at baseline [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Nutrient Adequacy Ratio (NAR) [Срок оценки: 3-month]
  • Mean Adequacy Ratio (MAR) [Срок оценки: 3-month]
  • Vegetarian life style index (VLI) [Срок оценки: 3-month]
  • Blood analysis- glucose [Срок оценки: 3-month]
  • Blood analysis- insulin [Срок оценки: 3-month]
  • Blood analysis- total cholesterol [Срок оценки: 3-month]
  • Blood analysis-LDL cholesterol [Срок оценки: 3-month]
  • Blood analysis-HDL cholesterol [Срок оценки: 3-month]
  • Blood analysis-triglycerides (mg/dl) [Срок оценки: 3-month]
  • Blood analysis- vitamins-B6 [Срок оценки: 3-month]
  • Blood analysis- vitamins-B12 [Срок оценки: 3-month]
  • Blood analysis- vitamins-folate [Срок оценки: 3-month]

Критерии участия

Критерии включения

  • 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;

Критерии исключения

  • 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • European Institute of Oncology, Milan, Recruiting — Milan

Идентификаторы

NCT: NCT07638839 · UID 4909 · L2-476

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗