Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The aim of the project is to study of the influence of Lettuce crop enriched with Iodine on
      Thyroid hormone synthesis. Secondary outcome to find out iodine presence in urine in order to
      evaluate vegetables, like little crop, as Iodine biocarrier
    

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. 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)
    

Intervention name(s): Lettuce with not biofortification; Lettuce biofortificated with Iodine
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; Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr 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; biocarrier; Iodine