Effects of Saline Eustress in Plant Food (ESEPF)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of the Potential Health Effects of Saline Eustress in Plant Food

Conditions
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Healthy Diet

Intervention / Treatment
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* Dietary Supplement: Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).
* Dietary Supplement: Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Italian age: 18-65 years currently injury free Body mass index between 18.5 and 28 kg/m2 Exclusion Criteria: Use of vitamins and minerals supplements, use of medications Presence of metabolic or chronic disease Pregnancy, breastfeeding condition, smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control vs intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>group that consumed control lettuce | Dietary Supplement: Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).<br>* Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day<br>* Other names: control lettuce;|
| Active Comparator: Intervention<br>group that consumed eustress lettuce | Dietary Supplement: Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.<br>* 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<br>* Other names: Eustress Intervention group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 days | 
| Bone metabolism markers | Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days. | 12 days | 
| Vitamin D | Vitamin D (microgram/L) will be assessed at baseline and after 12 days. | 12 days | 
| blood markers | Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days. | 12 days | 
| Potassium | Potassium (mmol/L) will be assessed at baseline and after 12 days. | 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. | 12 days | 
| Iron | iron (μg/dL) will be assessed in serum at baseline and after 12 days. | 12 days | 
| Ferritin | ferritin (ng/dL) will be assessed in serum at baseline and after 12 days. | 12 days | 
| transferrin | transferrin (mg/dL) will be assessed in serum at baseline and after 12 days. | 12 days | 
| % saturation of transferrin | % saturation of transferrin will be will be assessed in serum at baseline and after 12 days. | 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. | 12 days | 
| Insulin | insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days. | 12 days | 
| Glucose | Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days. | 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. | 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. | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 days |