Clinical trial NCT06656871: Biostimulants Application to Lettuce
Official title: Biostimulants Application to Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Dietary Deficiency
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of minerals concentration in participants
timeFrame: 4 weeks
measure: Measurement of iron concentration in participants
timeFrame: 4 weeks
measure: Measurement of Potassium concentration in participants
timeFrame: 4 weeks
Secondary outcomes:
measure: Measurement of ferritin in participants
timeFrame: 4 weeks
measure: Measurement of lipid metabolism markers in participants
timeFrame: 4 weeks
measure: Measurement of insulin in participants
timeFrame: 4 weeks
measure: Measurement of transferrin in participants
timeFrame: 4 weeks
measure: Measurement of % saturation of transferrin in participants
timeFrame: 4 weeks
measure: Measurement of glucose in participants
timeFrame: 4 weeks
Other outcomes:
measure: Measurement of Height in participants
timeFrame: 4 weeks
measure: Measurement of body mass index (BMI) in participants
timeFrame: 4 weeks
measure: Measurement of body weight in participants
timeFrame: 4 weeks
measure: Measurement of body composition in participants
timeFrame: 4 weeks
Locations:
city: Palermo
country: Italy
facility: NABbio, STEBICEF department
Study officials:
References:
citation: 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