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

• ClinicalTrials.gov Identifier: NCT06002672
• Recruitment Status: Completed
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Sponsor: University of Palermo
• Information provided by (Responsible Party): Sara Baldassano, University of Palermo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Diet	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.	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: control vs intervention
• Masking: Double (Participant, Investigator)
• Masking Description: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
• Primary Purpose: Prevention
• Official Title: Analysis of the Potential Health Effects of Saline Eustress in Plant Food
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: June 28, 2021

Arms and Interventions

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 Name: 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 Name: Eustress Intervention group

Outcome Measures

Primary Outcome Measures :

1. anthropometric measurement [ Time Frame: 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).
2. Bone metabolism markers [ Time Frame: 12 days ]
   Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
3. Vitamin D [ Time Frame: 12 days ]
   Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
4. blood markers [ Time Frame: 12 days ]
   Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
5. Potassium [ Time Frame: 12 days ]
   Potassium (mmol/L) will be assessed at baseline and after 12 days.
6. Bone remodelling markers [ Time Frame: 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.
7. Iron [ Time Frame: 12 days ]
   iron (μg/dL) will be assessed in serum at baseline and after 12 days.
8. Ferritin [ Time Frame: 12 days ]
   ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
9. transferrin [ Time Frame: 12 days ]
   transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
10. % saturation of transferrin [ Time Frame: 12 days ]
    % saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
11. markers of lipid metabolism [ Time Frame: 12 days ]
    triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
12. Insulin [ Time Frame: 12 days ]
    insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
13. Glucose [ Time Frame: 12 days ]
    Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
14. markers of hepatic metabolism [ Time Frame: 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.
15. Total protein (TP) and Albumin [ Time Frame: 12 days ]
    Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.

Secondary Outcome Measures :

1. body composition [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Italy

NABbio, STEBICEF department

Palermo, Italy, 90128

Sponsors and Collaborators

University of Palermo

Investigators

• Principal Investigator: Sara Baldassano; University of Palermo

More Information

• Responsible Party: Sara Baldassano, Professor, University of Palermo
• ClinicalTrials.gov Identifier: NCT06002672
• Other Study ID Numbers: Plant_Food_2021
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No