Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food (Nutri-I-Food)
Intervention Study With Crop Lettuce Enriched With Iodine
研究概览
地位
条件
详细说明
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)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Palermo、意大利、90141
- Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum Thyroid markers
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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炎症标志物
大体时间：10天
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将在基线和 10 天后评估血浆中测量的 IL-1 (pg/mL)、TNF(pg/mL)、IL-6(pg/mL)、IL-10(pg/mL)
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10天
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body mass index (BMI)
大体时间：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 (%)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Sonya Vasto, PhD、D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- Nutr-I-Food2019
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