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

Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum

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.

Study Overview

• Status: Completed
• Conditions: Healthy Diet
• Intervention / Treatment: Dietary supplement: Lettuce with no biofortification; Dietary supplement: Intervention Molibdenum group

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PA
    • Palermo, PA, Italy, 90141
      • Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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
Experimental: Experimental: intervention group; The intervention group was assigned to biofortificated Molibdenum crop lettuce.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Molibdenum concentration (mg/l)	Urine Molibdenum concentration (mg/l) will be assessed at baseline and after 10 days	10 days
Haematology and serum chemistry measurements	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	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body composition	lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days	10 days
Body mass Index (BMI) kg/m2	Weight (Kg), height (M), BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days	10 days
Gastric Hormones (pg/ml)	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	10 days
Oxidative stress marker (ng/mL)	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	10 days
Inflammatory markers (ng/ml)	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
Bone metabolism markers (pg/mL)	Osteocalcin(pg/mL), parathyroid hormone(pg/mL), CTX, Calcitonin(pg/mL) measured in plasma will be assessed at baseline and after 10 days	10 days

Collaborators and Investigators

• Sponsor: University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: functional food; molibdenum
• Other Study ID Numbers: Nutri-Mo-Food2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No