Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food ) (NutMoFood)
Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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)
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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PA
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Palermo, PA, Italia, 90141
- Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Urine Molibdenum concentration (mg/l)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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kroppssammensetning
Tidsramme: 10 dager
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mager masse som prosent av kroppsvekt og fettmasse som prosent av kroppsvekt vil bli vurdert ved baseline og etter 10 dager
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10 dager
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Body mass Index (BMI) kg/m2
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
10 days
|
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Bone metabolism markers (pg/mL)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Nutri-Mo-Food2021
Legemiddel- og utstyrsinformasjon, studiedokumenter
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