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NCT Number: NCT04984746

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

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.

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Key information

Conditions

Healthy Diet

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, PA, 90141, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: (control group)

Dietary Supplement

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

Experimental: intervention group

Dietary Supplement

Molybdenum Iodine group

Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce every day for 10 days

Primary outcomes

  1. Urine Molybdenum and Iodine concentration

    Time frame: 10 days

    Urine Iodine and Molybdenum concentration (mg/l) will be assessed at baseline and after 10 days

  2. Hematology and serum chemistry measurements

    Time frame: 10 days

    (glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL), AST (mg/dL), ALT (mg/dL), γ-GT(mg/dL), ALP(mg/dL), Ferritin (mg/dL), free Iron (mg/dL), transferrin (mg/dL), total proteins (mg/dL), Magnesium (mg/dL), Calcium (mg/dL), insulin (mg/dL), Vitamin D (mg/dL), HCRP (mg/dL), Potassium (mg/dL), Phosphate (mg/dL) All these measurements will be assessed at baseline and after 10 days

Secondary outcomes

  1. body mass index (BMI)

    Time frame: 10 days

    Weight (Kg) and Hight (m) will be measured and aggregated to arrive at one reported value. Therefore weight and height will be combined to report BMI (kg/m2)

    All these measurements will be assessed at baseline and after 10 days

  2. body composition

    Time frame: 10 days

    lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days

  3. Oxidative stress markers

    Time frame: 10 days

    DL-ox (ng/mL), AGE(ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) measured in in plasma will be assessed at baseline and after 10 days

  4. Bone turnover markers

    Time frame: 10 days

    Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX (ng/L), Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days

  5. Gastric hormones

    Time frame: 10 days

    • GIP (pg/ml), GLP1 (pg/ml), GLP2 (pg/ml), ghrelin (pg/ml), PYY (pg/ml), CCK(pg/ml) measured in plasma will be assessed at baseline and after 10 days

  6. Inflammatory markers

    Time frame: 10 days

    IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) measured in plasma will be assessed at baseline and after 10 days

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Intervention Study With Lettuces Enriched With Iodine and Molybdenum.

Acronym: Nutr-I-Mo

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2021
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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