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Completed

NCT Number: NCT04985240

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

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.

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Key information

Conditions

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

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)

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

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

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

Primary outcomes

  1. Urine Molibdenum concentration (mg/l)

    Time frame: 10 days

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

  2. Haematology and serum chemistry measurements

    Time frame: 10 days

    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

Secondary outcomes

  1. Body mass Index (BMI) kg/m2

    Time frame: 10 days

    Weight (Kg), height (M), 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. Gastric Hormones (pg/ml)

    Time frame: 10 days

    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

  4. Oxidative stress marker (ng/mL)

    Time frame: 10 days

    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

  5. Inflammatory markers (ng/ml)

    Time frame: 10 days

    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

  6. Bone metabolism markers (pg/mL)

    Time frame: 10 days

    Osteocalcin(pg/mL), parathyroid hormone(pg/mL), CTX, Calcitonin(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

Randomized Intervention Study With Crop Lettuce Enriched With Molybdenum

Acronym: NutMoFood

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.

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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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