Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology (VEGETARIANS)
2026年6月9日 更新者：European Institute of Oncology
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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (推定)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Patrizia Gnagnarella, PhD
- 電話番号：+39 0257489823
- メール：patrizia.gnagnarella@ieo.it
研究場所
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Milan、イタリア、20141
- 募集
- European Institute of Oncology, Milan, Recruiting
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コンタクト：
- Patrizia Gnagnarella
- 電話番号：+39 0257489823
- メール：patrizia.gnagnarella@ieo.it
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コンタクト：
- Davide Serrano
- メール：davide.serrano@ieo.it
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：vegetarian study population
The 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)
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Survey on nutritional adequacy of participants' diet at baseline
時間枠：Baseline
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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.
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Baseline
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Survey on dietary and lifestyle quality of participants at baseline
時間枠：Baseline
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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.
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Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Nutrient Adequacy Ratio (NAR)
時間枠：3-month
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change in NAR calculated by dividing participant's intake of a given nutrient by the Italian DRVs for the corresponding age category
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3-month
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Mean Adequacy Ratio (MAR)
時間枠：3-month
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change in MAR calculated by averaging all NARs together
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3-month
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Vegetarian life style index (VLI)
時間枠：3-month
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change in vegetarian Lifestyle score ranging from 0 to 14, with higher score indicating greater adherence.
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3-month
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Blood analysis- glucose
時間枠：3-month
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change in concentration of glucose (mg/dl)
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3-month
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Blood analysis- insulin
時間枠：3-month
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change in concentration of insulin (mUI/L)
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3-month
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Blood analysis- total cholesterol
時間枠：3-month
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change in concentration of total cholesterol (mg/dl)
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3-month
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Blood analysis-LDL cholesterol
時間枠：3-month
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change in concentration of LDL cholesterol (mg/dl)
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3-month
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Blood analysis-HDL cholesterol
時間枠：3-month
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change in concentration HDL cholesterol (mg/dl)
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3-month
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Blood analysis-triglycerides (mg/dl)
時間枠：3-month
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change in concentration of triglycerides (mg/dl)
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3-month
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Blood analysis- vitamins-B6
時間枠：3-month
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change in concentration of B6(mcg/L)
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3-month
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Blood analysis- vitamins-B12
時間枠：3-month
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change in concentration of B12 (ng/L)
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3-month
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Blood analysis- vitamins-folate
時間枠：3-month
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change in concentration of folate (mcg/L)
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3-month
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Blood analysis- vitamins-Vitamin D
時間枠：3-month
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change in concentration of Vitamin D (mcg/L)
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3-month
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Blood analysis- iron status
時間枠：3-month
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change in concentration of iron (mcg/dl)
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3-month
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Blood analysis- ferritin status
時間枠：3-month
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change in concentration of ferritin (mcg/L)
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3-month
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Blood analysis- Calcium
時間枠：3-month
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change in concentration of calcium (mg/dl)
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3-month
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Blood analysis- total protein
時間枠：3-month
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change in concentration of total protein (g/dl)
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3-month
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Anthropometric measurements - Body weight
時間枠：3-month
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change in Body weight (kg)
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3-month
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Anthropometric measurements - circumferences
時間枠：3-month
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change in waist and hip circumferences (cm)
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3-month
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Anthropometric measurements - Body composition
時間枠：3-month
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change in fat mass and fat free mass (kg)
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3-month
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Physical activity
時間枠：3-month
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change in metabolic equivalents of tasks (METs), measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf)
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3-month
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Quality of life (VEGQOL)
時間枠：3-month
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change in VEGQOL score ranging from 0-100 scale, with higer score indicating better QoL.
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3-month
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Adherence to the Mediterranean diet
時間枠：3-month
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change in Mediterranean diet adherence score ranging from 0 to 9, with higer scores indicating better adherence
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3-month
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Patrizia Gnagnarella, PhD、European Institute of Oncology
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月26日
一次修了 (推定)
2028年1月26日
研究の完了 (推定)
2028年1月26日
試験登録日
最初に提出
2026年3月25日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。