Health Effects of Biostimulated Lettuce in Human

Not Applicable

Completed

• Conditions: Bone Resorption; Glucose Metabolism Disorders; Lipid Metabolism Disorder; Hepatic Steatosis; Nutrition, Healthy; Dietary Deficiency
• Interventions: Dietary Supplement: Biostimulated group; Dietary Supplement: Control Group

• Registration Number: NCT05971017
• Lead Sponsor: University of Palermo

Brief 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.

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 Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-05-02
• Status Verified: 2023-07
• Study Completion: 2023-07-09
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-30
• Last Update Submitted: 2023-07-30
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biostimulated Group	Biostimulated group	experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
Control group	Control Group	To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)

Primary Outcome Measures

Name	Time	Method
Glucose metabolism	15 days	insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
Serum bone matabolism markers	15 days	bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
body mass index (BMI)	15 days	Weight (Kg) Height (m) BMI (kg/m2)
hepatic metabolism	15 days	AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
iron metabolism	15 days	ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
Lipid metabolism	15 days	triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Gastrointestinal peptides and lipid hormones	15 days	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.
Serum bone remodelling markers	15 days	PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.

Secondary Outcome Measures

Name	Time	Method
body composition	15 days	lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days

Trial Locations

Locations (1)

NABbio, STEBICEF department; 🇮🇹 Palermo, Italy