Nutrition, HealthySwE4WEEKSNCT06656871
Biostimulants Application to Lettuce
A study testing iron supplementation and Biostimulated lettuce supplementation in people with Nutrition, Healthy and Glucose Metabolism Disorders, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Glucose Metabolism Disorders, Lipid Metabolism Disorders
- What is being tested?
- iron supplementation and Biostimulated lettuce supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2023to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 - 70 years
- Italian Ethnicity
- Body mass index between 18.5 and 28.5 kg/m2
- Clinically Healthy
Who cannot join
- Chronic disease
- Use of drugs
- Pregnancy
- Exogenous hormones
- Breastfeeding
- Use of supplements
- sensitivity to lettuce
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Nutrition, Healthy, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Dietary Deficiency
- Being tested
- iron supplementation, Biostimulated lettuce supplementation
- Medical subject headings
- Glucose Metabolism Disorders, Lipid Metabolism Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron supplementationDietary supplement
The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks
Biostimulated lettuce supplementationDietary supplement
the intervention group SwE lettuce group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Biostimulated SwE lettuce intervention group | Experimental | The SwE lettuce intervention group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) for 4 weeks Receives: Dietary Supplement: Biostimulated lettuce supplementation |
| Iron tablet intervention group | Experimental | The iron tablet intervention group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks Receives: Dietary Supplement: iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Measurement of iron concentration in participants
Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks.
Measured: 4 weeks
Measurement of Potassium concentration in participants
Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks.
Measured: 4 weeks
Secondary outcomes (6)
Measurement of ferritin in participants
Ferritin (ng/dL) will be measured in serum at baseline and after 4 weeks
Measured: 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
Measured: 4 weeks
Measurement of insulin in participants
insulin (mUI/L) will be measured in serum at baseline and after 4 weeks
Measured: 4 weeks
Measurement of transferrin in participants
transferrin (mg/dL) will be measured in serum at baseline and after 4 weeks
Measured: 4 weeks
Measurement of % saturation of transferrin in participants
% saturation of transferrin will be measured in serum at baseline and after 4 weeks
Measured: 4 weeks
Measurement of glucose in participants
glucose (mg/dL) will be measured in serum at baseline and after 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start10 Jun 2023
- Primary completion10 Jul 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Baldassano, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656871
- Sponsor's protocol ID
- SwE4WEEKS23
- Acronym
- SwE4WEEKS
- Status last verified
- Mar 2023
- First submitted
- 19 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because is forbidden by the Italian Low
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
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.
PubMed 40050333
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biostimulants Application to Vegetables
- ClinicalTrials.gov ID
- NCT06656871
- Acronym / sponsor ID
- SwE4WEEKS / SwE4WEEKS23
- Conditions
- Nutrition, Healthy, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Dietary Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Biostimulated SwE lettuce intervention group | Experimental | Dietary Supplement: Biostimulated lettuce supplementationThe SwE lettuce intervention group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) for 4 weeks |
| Iron tablet intervention group | Experimental | Dietary Supplement: iron supplementationThe iron tablet intervention group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 - 70 years
- Italian Ethnicity
- Body mass index between 18.5 and 28.5 kg/m2
- Clinically Healthy
Key exclusion criteria (7 listed)
- Chronic disease
- Use of drugs
- Pregnancy
- Exogenous hormones
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron supplementationThe iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks | Dietary supplement | Iron tablet intervention group |
| Biostimulated lettuce supplementationthe intervention group SwE lettuce group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) daily for 4 weeks | Dietary supplement | Biostimulated SwE lettuce intervention group |
Primary outcome
Measurement of minerals concentration in participants
Time frame: 4 weeks
Calcium (mg/dL), Phosphate (mg/dL), Magnesium (mg/dL) will be assessed in serum at baseline and after 4 weeks.
Measurement of iron concentration in participants
Time frame: 4 weeks
Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks.
Measurement of Potassium concentration in participants
Time frame: 4 weeks
Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks.
6 secondary outcomes
Measurement of ferritin in participants
Time frame: 4 weeks
Measurement of lipid metabolism markers in participants
Time frame: 4 weeks
Measurement of insulin in participants
Time frame: 4 weeks
Measurement of transferrin in participants
Time frame: 4 weeks
Measurement of % saturation of transferrin in participants
Time frame: 4 weeks
Measurement of glucose in participants
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Backgroundttps://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
- Derived from this study: PubMed 40050333Di 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.
- Individual participant dataSharing planned: No. Because is forbidden by the Italian Low
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron supplementation and Biostimulated lettuce supplementation in people with Nutrition, Healthy and Glucose Metabolism Disorders, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of minerals concentration in participants (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656871, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.