NCT06002672

Effects of Saline Eustress in Plant Food (ESEPF)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Diet

Interventions

Type	Name	Description
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).	Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
DIETARY_SUPPLEMENT	Experimental: 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

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-04-01
• Completion: 2021-06-28
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: Italy