Effects of Saline Eustress in Plant Food (ESEPF)

Healthy Diet Clinical Trial

— ESEPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002672
• Other study ID #: Plant_Food_2021
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 28, 2021

Study information

• Verified date: August 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 28, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Diet

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	NABbio, STEBICEF department	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

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