Clinical trial NCT05011968: Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food
Official title: Intervention Study With Crop Lettuce Enriched With Iodine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals
Keywords: functional food
biocarrier
Iodine
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Serum Thyroid markers
timeFrame: 10 days
measure: Urine Iodine concentration
timeFrame: 10 days
measure: Haematology and serum chemistry values 1
timeFrame: 10 days
measure: Haematology and serum chemistry values 2
timeFrame: 10 days
measure: Haematology and serum chemistry values 3
timeFrame: 10 days
measure: Haematology and serum chemistry values 4
timeFrame: 10 days
measure: Haematology and serum chemistry values 5
timeFrame: 10 days
Secondary outcomes:
measure: body mass index (BMI)
timeFrame: 10 days
measure: body composition (%)
timeFrame: 10 days
measure: Gastric Hormones
timeFrame: 10 days
measure: Oxidative stress markes
timeFrame: 10 days
measure: Bone metabolism
timeFrame: 10 days
measure: Inflammatory markers
timeFrame: 10 days
measure: Weigh
timeFrame: 10 days
measure: Hight
timeFrame: 10 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Study officials:
affiliation: D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
name: Sonya Vasto, PhD
role: PRINCIPAL_INVESTIGATOR
References: