Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food (Nutri-I-Food)
Intervention Study With Crop Lettuce Enriched With Iodine
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Palermo, Italien, 90141
- Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Thyroid markers
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Inflammatoriska markörer
Tidsram: 10 dagar
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IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) mätt i plasma kommer att bedömas vid baslinjen och efter 10 dagar
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10 dagar
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body mass index (BMI)
Tidsram: 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 (%)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sonya Vasto, PhD, D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Nutr-I-Food2019
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