Clinical trial NCT04985240: Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food )
Official title: Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Keywords: functional food
molibdenum
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study were designed by two cohorts The control group and the interventional group. The intervention lasted for 10 days and 100gr of lettuce per day was consumed.
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Urine Molibdenum concentration (mg/l)
timeFrame: 10 days
measure: Haematology and serum chemistry measurements
timeFrame: 10 days
Secondary outcomes:
measure: Body mass Index (BMI) kg/m2
timeFrame: 10 days
measure: body composition
timeFrame: 10 days
measure: Gastric Hormones (pg/ml)
timeFrame: 10 days
measure: Oxidative stress marker (ng/mL)
timeFrame: 10 days
measure: Inflammatory markers (ng/ml)
timeFrame: 10 days
measure: Bone metabolism markers (pg/mL)
timeFrame: 10 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
state: PA
Study officials:
References: