Intervention Study on Iodine and Molybdenum Biofortification Vegetables ( Nutri-I-Mo )
Condition: Healthy Diet
Study type: Interventional

Summary: 
      The aim of the project is to study the influence of Lettuce crop enriched with Molybdenum and
      lettuce enriched with Iodine administrated at the same time on healthy population in order to
      assess influence on hematological parameter and Thyroid hormones. Secondary outcome will be
      to find out Molybdenum and Iodine presence in urine in order to evaluate vegetables as
      biocarrier and any additive effect when administrated all together.
    

Detailed description: 
      Several human pathologies are caused by deficiencies of some mineral elements. These
      deficiencies can be overcome through careful dietary diversification and mineral
      supplementation. Increasing the bioavailable mineral concentration in vegetables for human
      consumption could be a useful tool for prevention of 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 aims to investigate the benefits of fortified food intake in a cohort of
      healthy individuals. Specifically, participants will be fed with lettuce enriched with
      Molybdenum and lettuce enriched with Iodine in order to study any additional influence on
      hematological parameters of both minerals The healthy group will eat 100 gr of Lettuce with
      iodine and 100gr of lettuce with Molybdenum and collect plasma and urine samples after 10
      days. Each subject will be subjected to two venous blood samples taken at the beginning of
      the observation and at the end. The samples obtained will be transported in certified
      containers for the safe transport of biological samples, and, subsequently, processed by the
      experimenters at 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, hematocrit, hs-CRP, TSH, FT3, FT4. 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)
    

Intervention name(s): No Intervention: (control group); Experimental: intervention group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days; Molybdenum Iodine group
Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce every day for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study were designed by two cohorts The control group and the interventional group. The intervention lasted for 10 days and 100gr of lettuce per day was consumed.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: functional food; Iodine; Molybdenum