Health Effects of Biostimulated Lettuce in Human

Glucose Metabolism Disorders Clinical Trial

— NUTRIWEED23  

Official title:

Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05971017
• Other study ID #: Weed2023
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 9, 2023

Study information

• Verified date: July 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 9, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Resorption
• Dietary Deficiency
• Fatty Liver
• Glucose Metabolism Disorders
• Hepatic Steatosis
• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Malnutrition
• Metabolic Diseases

Intervention

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
• 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

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	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
Primary	iron metabolism	ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days	15 days
Primary	Lipid metabolism	triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days	15 days
Primary	Glucose metabolism	insulin, glucose will be measured in serum will be assessed at baseline and after 15 days	15 days
Primary	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
Primary	Serum bone remodelling markers	PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.	15 days
Primary	Serum bone matabolism markers	bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.	15 days
Primary	body mass index (BMI)	Weight (Kg) Height (m) BMI (kg/m2)	15 days
Secondary	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

External Links

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