Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2023-06-10
2023-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
No interventions assigned to this group
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
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
Iron tablet intervention group
The iron tablet intervention group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks
iron supplementation
The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks
Interventions
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iron supplementation
The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks
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
Eligibility Criteria
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Inclusion Criteria
* Italian Ethnicity
* Body mass index between 18.5 and 28.5 kg/m2
* Clinically Healthy
Exclusion Criteria
* Use of drugs
* Pregnancy
* Exogenous hormones
* Breastfeeding
* Use of supplements
* sensitivity to lettuce
20 Years
70 Years
ALL
Yes
Sponsors
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University of Palermo
OTHER
Responsible Party
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Sara Baldassano
Professor
Locations
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NABbio, STEBICEF department
Palermo, , Italy
Countries
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References
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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
Di Gaudio F, Vasto S, Sabatino L, Ferrantelli V, Macaluso A, Caldarella R, Di Rosa L, Caldara GF, Proia P, Baldassano S. Consumption of lettuce with seaweed extract biostimulant application improved iron homeostasis in a randomized interventional trial of healthy individuals. Sci Rep. 2025 Mar 6;15(1):7799. doi: 10.1038/s41598-025-91380-7.
Other Identifiers
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SwE4WEEKS23
Identifier Type: -
Identifier Source: org_study_id
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