NUTRIWEED23: Health Effects of Biostimulated Lettuce in Human

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT05971017

Collaborator

(none)

100

Enrollment

Location

Arms

4.3

Actual Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition, Healthy Dietary Deficiency Bone Resorption Glucose Metabolism Disorders Lipid Metabolism Disorder Hepatic Steatosis	Dietary Supplement: Control Group Dietary Supplement: Biostimulated group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

control group, biostimulated groupcontrol group, biostimulated group

Masking:

Single (Participant)

Masking Description:

Two groups that consumed lettuce. No differences in shape, size, colours of lettuce

Primary Purpose:

Prevention

Official Title:

Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population

Actual Study Start Date :

Mar 1, 2023

Actual Primary Completion Date :

May 2, 2023

Actual Study Completion Date :

Jul 9, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
Glucose metabolism [15 days]
insulin, glucose 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.
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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