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

NCT04985240 | Completed

• 1 other identifier: Nutri-Mo-Food2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet

Keywords

functional food; molibdenum

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Body mass Index (BMI) kg/m2

  10 days

• body composition

  10 days

• Gastric Hormones (pg/ml)

  10 days

• Oxidative stress marker (ng/mL)

  10 days

• Inflammatory markers (ng/ml)

  10 days

Study Arms (2)

No Intervention: (control group)

EXPERIMENTAL

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

Experimental: intervention group

EXPERIMENTAL

The intervention group was assigned to biofortificated Molibdenum crop lettuce.

Dietary Supplement: Intervention Molibdenum group

Interventions

Lettuce with no biofortification DIETARY_SUPPLEMENT

Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days

No Intervention: (control group)

Intervention Molibdenum group DIETARY_SUPPLEMENT

Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days

Experimental: intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian
• age: 18-65 years
• healthy status
• no drug therapy or integration therapy

You may not qualify if:

• Inflammatory chronic disease
• use of medication or suffering from any condition
• pregnancy
• breastfeeding
• current smokers

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Palermo, PA, 90141, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 2, 2021
• Study Start: April 1, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

IT (1)