Biostimulants Application to Lettuce

NCT06656871 | Completed

• 1 other identifier: SwE4WEEKS23
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Nutrition, Healthy; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Dietary Deficiency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Measurement of ferritin in participants

  4 weeks

• Measurement of lipid metabolism markers in participants

  4 weeks

• Measurement of insulin in participants

  4 weeks

• Measurement of transferrin in participants

  4 weeks

• Measurement of % saturation of transferrin in participants

  4 weeks

Other Outcomes (4)

• Measurement of Height in participants

  4 weeks

• Measurement of body mass index (BMI) in participants

  4 weeks

• Measurement of body weight in participants

  4 weeks

Study Arms (3)

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

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

Dietary Supplement: iron supplementation

Interventions

iron supplementation DIETARY_SUPPLEMENT

The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks

Iron tablet intervention group

Biostimulated lettuce supplementation DIETARY_SUPPLEMENT

the intervention group SwE lettuce group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) daily for 4 weeks

Biostimulated SwE lettuce intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

NABbio, STEBICEF department

Palermo, 90128, Italy

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 40050333 DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders; Lipid Metabolism Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 24, 2024
• Study Start: June 10, 2023
• Primary Completion: July 10, 2023
• Study Completion: September 10, 2023
• Last Updated: October 24, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)