Effects of Saline Eustress in Plant Food (ESEPF) (ESEPF)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Diet
• Intervention / Treatment: 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90128
    • NABbio, STEBICEF department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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).; Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day; Other Names: control lettuce
Active Comparator: Intervention; group that consumed eustress lettuce	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; Other Names: Eustress Intervention group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Sara Baldassano, University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Plant_Food_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No