Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656871
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Biostimulants Application to Lettuce
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biostimulants Application to Vegetables
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SwE4WEEKS
Brief Summary:
Biostimulants application to vegetables is a useful agronomic approach to reduce the use of pesticides and to improve crop yield and quality by a naturally functionalizing process The aim of the study is to verify the effects of a nutritional intervention with lettuce Biostimulated by application of seaweed extracts derived from Ecklonia maxima SwE in a healthy population in order to assess influence on specific essential minerals like calcium potassium iron magnesium phosphorous Primary outcome and metabolisms like glucose lipid iron homeostasis Secondary outcome
Detailed Description:
The present project aims to investigate the benefits of biostimulants lettuce in a cohort of healthy individuals Biostimulants are organic and inorganic compounds or microorganisms that when applied to plants can enhance plants growth yield and tolerance to stress Seaweed extract treatment seems to enhance mineral concentration in crops Participants will be fed with biostimulated lettuce or a tablet of iron daily in order to study the influence on hematological parameters
A cohort of healthy subjects will be divided into a control group receiving control lettuce lettuce SwE group receiving biostimulated lettuce and iron tablet group receiving iron bisglycinate 30 mg supplement in tablet for a total of 4 weeks Blood samples will be collected in specific tubes before baseline and after the nutritional intervention T2 The group will eat 100 grams of Lettuce control group and 100 grams of SwE Biostimulated lettuce intervention group lettuce for 4 weeks 100 gramsdaily or a tablet of iron intervention group iron tablet and collect blood samples serum and plasma baseline before starting the nutritional intervention and after 4 weeks T2
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 insulin total cholesterol HDL-cholesterol LDL-cholesterol triglycerides Ferritin Iron transferrin Magnesium Calcium Potassium Phosphate Potassium
Statistical analysis plan
Student t tests will be used to compare the baseline characteristics of the groups Changes between baseline and follow-up will be analyzed by one-way ANOVA followed by Sidak post test A P 005 will be considered to be statistically significant by using appropriate software
A cohort of healthy subjects will be divided into a control group receiving control lettuce lettuce SwE group receiving biostimulated lettuce and iron tablet group receiving iron bisglycinate 30 mg supplement in tablet for a total of 4 weeks Blood samples will be collected in specific tubes before baseline and after the nutritional intervention T2 The group will eat 100 grams of Lettuce control group and 100 grams of SwE Biostimulated lettuce intervention group lettuce for 4 weeks 100 gramsdaily or a tablet of iron intervention group iron tablet and collect blood samples serum and plasma baseline before starting the nutritional intervention and after 4 weeks T2
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 insulin total cholesterol HDL-cholesterol LDL-cholesterol triglycerides Ferritin Iron transferrin Magnesium Calcium Potassium Phosphate Potassium
Statistical analysis plan
Student t tests will be used to compare the baseline characteristics of the groups Changes between baseline and follow-up will be analyzed by one-way ANOVA followed by Sidak post test A P 005 will be considered to be statistically significant by using appropriate software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None