Healthy Diet
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo 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).
Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
DIETARY_SUPPLEMENTExperimental: Eustress group. To the intervention Eustress group was assigned the eustress 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
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
Intervention model description
control vs intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| blood markers | 12 days | Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days. |
| Potassium | 12 days | Potassium (mmol/L) will be assessed 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. |
| 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. |
| transferrin | 12 days | transferrin (mg/dL) will be assessed in serum 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed