Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food (Nutri-I-Food)

Intervention Study With Crop Lettuce Enriched With Iodine

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

Study Overview

• Status: Completed
• Conditions: Healthy Individuals
• Intervention / Treatment: Dietary supplement: Lettuce with not biofortification; Dietary supplement: Lettuce biofortificated with Iodine

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90141
    • Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Dietary supplement: Lettuce with not biofortification; Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
Experimental: Experimental: intervention group; The intervention group was assigned to biofortificated Iodine crop lettuce.	Dietary supplement: Lettuce biofortificated with Iodine; Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Thyroid markers	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	10 days
Urine Iodine concentration	Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days	10 days
Haematology and serum chemistry values 1	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	10 days
Haematology and serum chemistry values 2	insulin (mUI/L) will be assessed at baseline and after 10 days	10 days
Haematology and serum chemistry values 3	Potassium (mmol/L) will be assessed at baseline and after 10 days	10 days
Haematology and serum chemistry values 4	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	10 days
Haematology and serum chemistry values 5	AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) measured in plasma will be assessed at baseline and after 10 days	10 days
body mass index (BMI)	BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days	10 days
body composition (%)	lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days	10 days
Gastric Hormones	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	10 days
Oxidative stress markes	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	10 days
Bone metabolism	Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days	10 days
Weigh	Weight (Kg) will be assessed at baseline and after 10 days	10 days
Hight	Hight (m) will be assessed at baseline and after 10 days	10 days

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Sonya Vasto, PhD, D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Iodine; functional food; biocarrier
• Other Study ID Numbers: Nutr-I-Food2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No