Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food (Nutri-I-Food)
Intervention Study With Crop Lettuce Enriched With Iodine
調査の概要
状態
条件
詳細な説明
Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.
The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Palermo、イタリア、90141
- Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Caucasian
- age: 18-65 years
- healthy status
- no drug therapy or integration therapy
Exclusion Criteria:
- Inflammatory chronic disease
- use of medication or suffering from any condition
- pregnancy
- breastfeeding
- current smokers
研究計画
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：ランダム化
- 介入モデル：並列代入
- 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：No Intervention: (control group)
The control group was assigned to crop lettuce without any biofortification but with the same characteristic of bioforticated lettuce (soil, water, harvesting time)
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Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
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実験的：Experimental: intervention group
The intervention group was assigned to biofortificated Iodine crop lettuce.
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Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
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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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Serum Thyroid markers
時間枠：10 days
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serum levels of free tri-iodothyronine (FT3 ng/L), free thyroxine (FT4 ng/L) and thyroid-stimulating hormone (TSH ng/L) will be assessed at baseline and after 10 days
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10 days
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Urine Iodine concentration
時間枠：10 days
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Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 1
時間枠：10 days
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glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 2
時間枠：10 days
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insulin (mUI/L) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 3
時間枠：10 days
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Potassium (mmol/L) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 4
時間枠：10 days
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Ferritin (mg/L), free Iron (mg/L), transferrin (mg/L), total proteins (mg/L), Magnesium (mg/L), Calcium (mg/L), Vitamin D (mg/L), HCRP (mg/L), Phosphate (mg/L), Cortisol (mg/L)will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 5
時間枠：10 days
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AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days
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10 days
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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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炎症マーカー
時間枠：10日間
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血漿中で測定されたIL-1 (pg/mL)、TNF(pg/mL)、IL-6(pg/mL)、IL-10(pg/mL)は、ベースライン時と10日後に評価されます。
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10日間
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body mass index (BMI)
時間枠：10 days
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BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days
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10 days
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body composition (%)
時間枠：10 days
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lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days
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10 days
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Gastric Hormones
時間枠：10 days
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GIP (pg/m), GLP1 (pg/m), GLP2 (pg/m), ghrelin (pg/m), glucagon (pg/m), PYY (pg/m), CCK(pg/m) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Oxidative stress markes
時間枠：10 days
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LDL-ox (ug/mL), AGE(ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) will be assessed at baseline and after 10 days
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10 days
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Bone metabolism
時間枠：10 days
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Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Weigh
時間枠：10 days
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Weight (Kg) will be assessed at baseline and after 10 days
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10 days
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Hight
時間枠：10 days
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Hight (m) will be assessed at baseline and after 10 days
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10 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sonya Vasto, PhD、D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Nutr-I-Food2019
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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