Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food ) (NutMoFood)
Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum
Aperçu de l'étude
Statut
Les conditions
Description détaillée
everal 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, we have fed healthy individuals with lettuce enriched with Molibdenum and collected plasma and urine samples after 7-10 days. Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples thus obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at 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, 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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PA
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Palermo, PA, 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 Molibdenum 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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Urine Molibdenum concentration (mg/l)
Délai: 10 days
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Urine Molibdenum 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 measurements
Délai: 10 days
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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, Vitamin D Calcium, HCRP, Potassium, Phosphate, 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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la composition corporelle
Délai: 10 jours
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la masse maigre en pourcentage du poids corporel et la masse grasse en pourcentage du poids corporel seront évaluées au départ et après 10 jours
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10 jours
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Body mass Index (BMI) kg/m2
Délai: 10 days
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Weight (Kg), height (M), 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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Gastric Hormones (pg/ml)
Délai: 10 days
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GIP(pg/ml), GLP1(pg/ml), GLP2(pg/ml), ghrelin(pg/ml), glucagon(pg/ml), PYY(pg/ml), CCK(pg/ml) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Oxidative stress marker (ng/mL)
Délai: 10 days
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LDL-ox (ng/mL), AGE (ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Inflammatory markers (ng/ml)
Délai: 10 days
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IL-1 (ng/ml), TNF(ng/ml), IL-6(ng/ml), IL-10(ng/ml) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Bone metabolism markers (pg/mL)
Délai: 10 days
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Osteocalcin(pg/mL), parathyroid hormone(pg/mL), CTX, Calcitonin(pg/mL) measured in plasma will be assessed at baseline and after 10 days
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10 days
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Collaborateurs et enquêteurs
Parrainer
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
- Nutri-Mo-Food2021
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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