NABbio, STEBICEF department
Palermo, 90128, Italy
NCT Number: NCT06002672
The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Palermo, 90128, Italy
Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 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, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
Other names: control lettuce
100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days
Other names: Eustress Intervention group
Time frame: 12 days
weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m^2).
Time frame: 12 days
Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
Time frame: 12 days
Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
Time frame: 12 days
Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
Time frame: 12 days
Potassium (mmol/L) will be assessed at baseline and after 12 days.
Time frame: 12 days
markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Time frame: 12 days
insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Time frame: 12 days
Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Time frame: 12 days
Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
lean mass as percent of body weight and fat mass as percent of body weight will be will be assessed at baseline and after 12 days
University of Palermo
Other
Analysis of the Potential Health Effects of Saline Eustress in Plant Food
Acronym: ESEPF
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