Effects of Saline Eustress in Plant Food (ESEPF)
- Conditions
- Healthy Diet
- Registration Number
- NCT06002672
- Lead Sponsor
- University of Palermo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Italian
- age: 18-65 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
- Use of vitamins and minerals supplements,
- use of medications
- Presence of metabolic or chronic disease
- Pregnancy, breastfeeding condition,
- smokers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Potassium 12 days Potassium (mmol/L) will be assessed at baseline and after 12 days.
Iron 12 days iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Ferritin 12 days ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
blood markers 12 days Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
% saturation of transferrin 12 days % saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
transferrin 12 days transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
markers of lipid metabolism 12 days triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Insulin 12 days insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Glucose 12 days Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
anthropometric measurement 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).
Bone metabolism markers 12 days Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
Vitamin D 12 days Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
markers of hepatic metabolism 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.
Bone remodelling markers 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.
Total protein (TP) and Albumin 12 days Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
- Secondary Outcome Measures
Name Time Method body composition 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
Trial Locations
- Locations (1)
NABbio, STEBICEF department
🇮🇹Palermo, Italy