Skip to main content
OpenTrials
Completed

NCT Number: NCT05011968

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Individuals

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Palermo, 90141, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lettuce with not biofortification

Dietary Supplement

Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days

Lettuce biofortificated with Iodine

Dietary Supplement

Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days

Primary outcomes

  1. Serum Thyroid markers

    Time frame: 10 days

    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

  2. Urine Iodine concentration

    Time frame: 10 days

    Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days

  3. Haematology and serum chemistry values 1

    Time frame: 10 days

    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

  4. Haematology and serum chemistry values 2

    Time frame: 10 days

    insulin (mUI/L) will be assessed at baseline and after 10 days

  5. Haematology and serum chemistry values 3

    Time frame: 10 days

    Potassium (mmol/L) will be assessed at baseline and after 10 days

  6. Haematology and serum chemistry values 4

    Time frame: 10 days

    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

  7. Haematology and serum chemistry values 5

    Time frame: 10 days

    AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days

Secondary outcomes

  1. body mass index (BMI)

    Time frame: 10 days

    BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days

  2. body composition (%)

    Time frame: 10 days

    lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days

  3. Gastric Hormones

    Time frame: 10 days

    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

  4. Oxidative stress markes

    Time frame: 10 days

    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

  5. Bone metabolism

    Time frame: 10 days

    Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days

  6. Inflammatory markers

    Time frame: 10 days

    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

  7. Weigh

    Time frame: 10 days

    Weight (Kg) will be assessed at baseline and after 10 days

  8. Hight

    Time frame: 10 days

    Hight (m) will be assessed at baseline and after 10 days

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Intervention Study With Crop Lettuce Enriched With Iodine

Acronym: Nutri-I-Food

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 18, 2021
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.