Health Effects of Biostimulated Lettuce in Human (NUTRIWEED23)

Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population

The aim of the project is to study the influence of biostimulate crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Bone Resorption; Hepatic Steatosis; Nutrition, Healthy; Dietary Deficiency; Lipid Metabolism Disorder
• Intervention / Treatment: Dietary supplement: Control Group; Dietary supplement: Biostimulated group

Detailed Description

The aim of the project is to study the influence of biostimulated crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum in order to evaluate vegetables as carrier. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.

The present project aims to investigate the benefits of biostimulated lettuce in a cohort of healthy individuals. For biostimulation are used organic and inorganic compounds or microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance to stress. Participants will be fed with differently biostimulated lettuces to study the influence on hematological parameters.

The healthy group will eat 100 gr of Lettuce and 100 gr of biostimulated lettuce and will be collect plasma and urine samples after 15 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, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK, leptin, resistin).

• Study Type: Interventional
• Enrollment (Actual): 100
• 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:

• Inclusion Criteria:

  • Caucasian
  • age: 18-90 years
  • currently injury free
  • Body mass index between 18.5 and 28 kg/m2

Exclusion Criteria:

Exclusion Criteria:

• bone fracture within the previous year
• use of medication or suffering from any condition known to affect bone, lipid, glucose, iron metabolism
• pregnancy
• breastfeeding
• current smokers

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)	Dietary supplement: Control Group; Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days; Other Names: Placebo Comparator
Experimental: Biostimulated Group; experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.	Dietary supplement: Biostimulated group; Intervention biostimulated group 100gr of biostimulated lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 15 days; Other Names: Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hepatic metabolism	AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days	15 days
iron metabolism	ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days	15 days
Lipid metabolism	triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days	15 days
Glucose metabolism	insulin, glucose will be measured in serum will be assessed at baseline and after 15 days	15 days
Gastrointestinal peptides and lipid hormones	Plasma concentrations of Gastrointestinal peptides (GLP-1, GLP-2, GIP, PYY, Ghrelin) and lipid hormones (leptin, resistin, adiponectin) will be assessed at baseline and after and after 15 days.	15 days
Serum bone remodelling markers	PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.	15 days
Serum bone matabolism markers	bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.	15 days
body mass index (BMI)	Weight (Kg) Height (m) BMI (kg/m2)	15 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 assessed at baseline and after 15 days	15 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Plant-Derived Biostimulated Differentially Modulate Primary and Secondary Metabolites and Improve the Yield Potential of Red and Green Lettuce Cultivars

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): July 9, 2023

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Nutrition Disorders; Musculoskeletal Diseases; Bone Diseases; Fatty Liver; Malnutrition; Bone Resorption; Metabolic Diseases; Lipid Metabolism Disorders; Glucose Metabolism Disorders
• Other Study ID Numbers: Weed2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because is forbidden by the Italian Low

Drug and device information, study documents

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