Biostimulants Application to Lettuce (SwE4WEEKS)

Biostimulants Application to Vegetables

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).

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Lipid Metabolism Disorders; Nutrition, Healthy; Dietary Deficiency
• Intervention / Treatment: Dietary supplement: Biostimulated lettuce supplementation; Dietary supplement: iron supplementation

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 grams/daily) 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 < 0.05 will be considered to be statistically significant by using appropriate software.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90128
    • NABbio, STEBICEF department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 20 - 70 years
• Italian Ethnicity
• Body mass index between 18.5 and 28.5 kg/m2
• Clinically Healthy

Exclusion Criteria:

• Chronic disease
• Use of drugs
• Pregnancy
• Exogenous hormones
• Breastfeeding
• Use of supplements
• sensitivity to lettuce

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group received lettuce (control lettuce 100 grams/day) that was without any biostimulation with Ecklonia Maxima algae but with the same characteristic of SwE lettuce (soil, water, harvesting time) for 4 weeks.
Experimental: Biostimulated SwE lettuce intervention group; The SwE lettuce intervention group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) for 4 weeks	Dietary supplement: Biostimulated lettuce supplementation; the intervention group SwE lettuce group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) daily for 4 weeks
Experimental: Iron tablet intervention group; The iron tablet intervention group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks	Dietary supplement: iron supplementation; The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of minerals concentration in participants	Calcium (mg/dL), Phosphate (mg/dL), Magnesium (mg/dL) will be assessed in serum at baseline and after 4 weeks.	4 weeks
Measurement of iron concentration in participants	Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks.	4 weeks
Measurement of Potassium concentration in participants	Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of ferritin in participants	Ferritin (ng/dL) will be measured in serum at baseline and after 4 weeks	4 weeks
Measurement of lipid metabolism markers in participants	triglicerises, HDL, LDL, cholesterol (in mg/dL) will be measured in serum at baseline and after 4 weeks	4 weeks
Measurement of insulin in participants	insulin (mUI/L) will be measured in serum at baseline and after 4 weeks	4 weeks
Measurement of transferrin in participants	transferrin (mg/dL) will be measured in serum at baseline and after 4 weeks	4 weeks
Measurement of % saturation of transferrin in participants	% saturation of transferrin will be measured in serum at baseline and after 4 weeks	4 weeks
Measurement of glucose in participants	glucose (mg/dL) will be measured in serum at baseline and after 4 weeks	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Height in participants	Height (meters) will be assessed at baseline and after 4 weeks	4 weeks
Measurement of body mass index (BMI) in participants	weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will becombined to report BMI in kg/m^2).	4 weeks
Measurement of body weight in participants	Body weight (kg) will be assessed at baseline and after 4 weeks	4 weeks
Measurement of body composition in participants	lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 4 weeks	4 weeks

Collaborators and Investigators

• Sponsor: University of Palermo

Publications and helpful links

General Publications

• ttps://www.mdpi.com/2073-4395/12/6/1361 Description: Plant-Derived Biostimulants Differentially Modulate Primary and Secondary Metabolites and Improvethe Yield Potential of Red and Green Lettuce Cultivars

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): September 10, 2023

Study Registration Dates

• First Submitted: October 19, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Metabolic Diseases; Lipid Metabolism Disorders; Glucose Metabolism Disorders
• Other Study ID Numbers: SwE4WEEKS23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because is forbidden by the Italian Low

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No