An interventional study of No Intervention: (control group) and Experimental: intervention group in Healthy Diet, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-02.
Sponsored by University of Palermo · Not applicable, Interventional, and Prevention
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.
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)
University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Dietary Supplement: No Intervention: (control group)
Experimental: intervention group To the intervention group was assigned the biofortificated Molibdenum lettuce and Iodine lettuce.
Dietary Supplement: Experimental: intervention group
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
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
Urine Molybdenum and Iodine concentration
Urine Iodine and Molybdenum concentration (mg/l) will be assessed at baseline and after 10 days
Time frame: 10 days
Hematology and serum chemistry measurements
(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
Time frame: 10 days
body mass index (BMI)
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
Time frame: 10 days
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
Time frame: 10 days
Oxidative stress markers
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
Time frame: 10 days
Bone turnover markers
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
Time frame: 10 days
Gastric hormones
7. 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
Time frame: 10 days
Inflammatory markers
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
Time frame: 10 days
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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