Health Effects of Biostimulated Lettuce in Human (NUTRIWEED23)
Primary Purpose
Nutrition, Healthy, Dietary Deficiency, Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Control Group
Biostimulated group
Sponsored by
About this trial
This is an interventional prevention trial for Nutrition, Healthy
Eligibility Criteria
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
Sites / Locations
- NABbio, STEBICEF department
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Biostimulated Group
Arm Description
To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)
experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
Outcomes
Primary Outcome Measures
hepatic metabolism
AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
iron metabolism
ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
Lipid metabolism
triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Glucose metabolism
insulin, glucose will be measured in serum will be assessed at baseline and after 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.
Serum bone remodelling markers
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.
Serum bone matabolism markers
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
body mass index (BMI)
Weight (Kg) Height (m) BMI (kg/m2)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05971017
Brief Title
Health Effects of Biostimulated Lettuce in Human
Acronym
NUTRIWEED23
Official Title
Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
July 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Healthy, Dietary Deficiency, Bone Resorption, Glucose Metabolism Disorders, Lipid Metabolism Disorder, Hepatic Steatosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control group, biostimulated group
Masking
Participant
Masking Description
Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)
Arm Title
Biostimulated Group
Arm Type
Experimental
Arm Description
experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Group
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Biostimulated group
Other Intervention Name(s)
Intervention group
Intervention Description
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
Primary Outcome Measure Information:
Title
hepatic metabolism
Description
AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
Time Frame
15 days
Title
iron metabolism
Description
ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
Time Frame
15 days
Title
Lipid metabolism
Description
triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Time Frame
15 days
Title
Glucose metabolism
Description
insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
Time Frame
15 days
Title
Gastrointestinal peptides and lipid hormones
Description
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.
Time Frame
15 days
Title
Serum bone remodelling markers
Description
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.
Time Frame
15 days
Title
Serum bone matabolism markers
Description
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
Time Frame
15 days
Title
body mass index (BMI)
Description
Weight (Kg) Height (m) BMI (kg/m2)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
body composition
Description
lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Baldassano Professor, PhD
Organizational Affiliation
University of Palermo
Official's Role
Principal Investigator
Facility Information:
Facility Name
NABbio, STEBICEF department
City
Palermo
ZIP/Postal Code
90128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Because is forbidden by the Italian Low
Links:
URL
https://www.mdpi.com/2073-4395/12/6/1361
Description
Plant-Derived Biostimulated Differentially Modulate Primary and Secondary Metabolites and Improve the Yield Potential of Red and Green Lettuce Cultivars
Learn more about this trial
Health Effects of Biostimulated Lettuce in Human
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