Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food )
NCT ID: NCT04985240
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-04-01
2021-07-15
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
Lettuce with no biofortification
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
Experimental: intervention group
The intervention group was assigned to biofortificated Molibdenum crop lettuce.
Intervention Molibdenum group
Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
Interventions
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Lettuce with no biofortification
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
Intervention Molibdenum group
Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
Eligibility Criteria
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Inclusion Criteria
* age: 18-65 years
* healthy status
* no drug therapy or integration therapy
Exclusion Criteria
* use of medication or suffering from any condition
* pregnancy
* breastfeeding
* current smokers
18 Years
65 Years
ALL
Yes
Sponsors
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University of Palermo
OTHER
Responsible Party
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Sonya Vasto
Associate professor
Locations
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Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Palermo, PA, Italy
Countries
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Other Identifiers
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Nutri-Mo-Food2021
Identifier Type: -
Identifier Source: org_study_id
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