Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food (Nutri-I-Food)
Intervention Study With Crop Lettuce Enriched With Iodine
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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)
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Palermo, Italie, 90141
- Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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)
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Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
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Expérimental: Experimental: intervention group
The intervention group was assigned to biofortificated Iodine crop lettuce.
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Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Thyroid markers
Délai: 10 days
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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
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10 days
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Urine Iodine concentration
Délai: 10 days
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Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 1
Délai: 10 days
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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
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10 days
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Haematology and serum chemistry values 2
Délai: 10 days
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insulin (mUI/L) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 3
Délai: 10 days
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Potassium (mmol/L) will be assessed at baseline and after 10 days
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10 days
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Haematology and serum chemistry values 4
Délai: 10 days
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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
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10 days
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Haematology and serum chemistry values 5
Délai: 10 days
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AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days
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10 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Marqueurs inflammatoires
Délai: 10 jours
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IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) mesurés dans le plasma seront évalués au départ et après 10 jours
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10 jours
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body mass index (BMI)
Délai: 10 days
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BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days
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10 days
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body composition (%)
Délai: 10 days
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lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days
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10 days
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Gastric Hormones
Délai: 10 days
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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
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10 days
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Oxidative stress markes
Délai: 10 days
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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
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10 days
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Bone metabolism
Délai: 10 days
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Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Weigh
Délai: 10 days
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Weight (Kg) will be assessed at baseline and after 10 days
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10 days
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Hight
Délai: 10 days
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Hight (m) will be assessed at baseline and after 10 days
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10 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sonya Vasto, PhD, D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Nutr-I-Food2019
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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