Clinical trial NCT06002672: Effects of Saline Eustress in Plant Food (ESEPF)
Official title: Analysis of the Potential Health Effects of Saline Eustress in Plant Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control vs intervention
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: anthropometric measurement
timeFrame: 12 days
measure: Bone metabolism markers
timeFrame: 12 days
measure: Vitamin D
timeFrame: 12 days
measure: blood markers
timeFrame: 12 days
measure: Potassium
timeFrame: 12 days
measure: Bone remodelling markers
timeFrame: 12 days
measure: Iron
timeFrame: 12 days
measure: Ferritin
timeFrame: 12 days
measure: transferrin
timeFrame: 12 days
measure: % saturation of transferrin
timeFrame: 12 days
measure: markers of lipid metabolism
timeFrame: 12 days
measure: Insulin
timeFrame: 12 days
measure: Glucose
timeFrame: 12 days
measure: markers of hepatic metabolism
timeFrame: 12 days
measure: Total protein (TP) and Albumin
timeFrame: 12 days
Secondary outcomes:
measure: body composition
timeFrame: 12 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: NABbio, STEBICEF department
Study officials:
affiliation: University of Palermo
name: Sara Baldassano
role: PRINCIPAL_INVESTIGATOR
References: