Intervention Study on Iodine and Molybdenum Biofortification Vegetables ( Nutri-I-Mo ) (Nutr-I-Mo)

U

University of Palermo

Status

Completed

Conditions

Healthy Diet

Treatments

Dietary Supplement: Experimental: intervention group
Dietary Supplement: No Intervention: (control group)

Study type

Interventional

Funder types

Other

Identifiers

NCT04984746
Nutr-I-Mo-2021

Details and patient eligibility

About

The aim of the project is to study the influence of Lettuce crop enriched with Molybdenum and lettuce enriched with Iodine administrated at the same time on healthy population in order to assess influence on hematological parameter and Thyroid hormones. Secondary outcome will be to find out Molybdenum and Iodine presence in urine in order to evaluate vegetables as biocarrier and any additive effect when administrated all together.

Full description

Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. Increasing the bioavailable mineral concentration in vegetables for human consumption could be a useful tool for prevention of 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 aims to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, participants will be fed with lettuce enriched with Molybdenum and lettuce enriched with Iodine in order to study any additional influence on hematological parameters of both minerals The healthy group will eat 100 gr of Lettuce with iodine and 100gr of lettuce with Molybdenum and collect plasma and urine samples after 10 days. Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples 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, TSH, FT3, FT4. 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)

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

No Intervention: (control group)
Experimental group
Description:
No Intervention: (control group) The control group was assigned to lettuce without any biofortification but with the same characteristic of bioforticated lettuce(soil, water, harvesting time).
Treatment:
Dietary Supplement: No Intervention: (control group)
Experimental: intervention group
Experimental group
Description:
Experimental: intervention group To the intervention group was assigned the biofortificated Molibdenum lettuce and Iodine lettuce.
Treatment:
Dietary Supplement: Experimental: intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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