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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
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
NABbio, STEBICEF department
Palermo, Italy
anthropometric measurement
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
Bone metabolism markers
Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
Time frame: 12 days
Vitamin D
Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
Time frame: 12 days
blood markers
Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
Time frame: 12 days
Potassium
Potassium (mmol/L) will be assessed at baseline and after 12 days.
Time frame: 12 days
Bone remodelling markers
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
iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
Ferritin
ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
transferrin
transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
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Time frame: 12 days
% saturation of transferrin
% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
markers of lipid metabolism
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
insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Time frame: 12 days
Glucose
Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Time frame: 12 days
markers of hepatic metabolism
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
Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
Time frame: 12 days
body composition
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
Time frame: 12 days