NCT04985240

Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food )

Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the project is to study of the influence of Lettuce crop enriched with Molibdenum on hematological parameter. Secondary outcome to find out Molibdenum presence in urine in order to evaluate vegetables, like little crop, as Molibdenum biocarrier.

Detailed description

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)

Conditions

• Healthy Diet

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2021-08-02
• Last updated: 2021-08-02

Locations

1 site across 1 country: Italy