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Completed

NCT Number: NCT06656871

Biostimulants Application to Lettuce

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).

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Key information

Conditions

Nutrition, Healthy Dietary Deficiency Glucose Metabolism Disorders Lipid Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NABbio, STEBICEF department

Palermo, 90128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron supplementation

Dietary Supplement

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

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

Primary outcomes

  1. 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.

  2. Measurement of iron concentration in participants

    Time frame: 4 weeks

    Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks.

  3. Measurement of Potassium concentration in participants

    Time frame: 4 weeks

    Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks.

Secondary outcomes

  1. Measurement of ferritin in participants

    Time frame: 4 weeks

    Ferritin (ng/dL) will be measured in serum at baseline and after 4 weeks

  2. Measurement of lipid metabolism markers in participants

    Time frame: 4 weeks

    triglicerises, HDL, LDL, cholesterol (in mg/dL) will be measured in serum at baseline and after 4 weeks

  3. Measurement of insulin in participants

    Time frame: 4 weeks

    insulin (mUI/L) will be measured in serum at baseline and after 4 weeks

  4. Measurement of transferrin in participants

    Time frame: 4 weeks

    transferrin (mg/dL) will be measured in serum at baseline and after 4 weeks

  5. Measurement of % saturation of transferrin in participants

    Time frame: 4 weeks

    % saturation of transferrin will be measured in serum at baseline and after 4 weeks

  6. Measurement of glucose in participants

    Time frame: 4 weeks

    glucose (mg/dL) will be measured in serum at baseline and after 4 weeks

Other outcomes

  1. Measurement of Height in participants

    Time frame: 4 weeks

    Height (meters) will be assessed at baseline and after 4 weeks

  2. Measurement of body mass index (BMI) in participants

    Time frame: 4 weeks

    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).

  3. Measurement of body weight in participants

    Time frame: 4 weeks

    Body weight (kg) will be assessed at baseline and after 4 weeks

  4. Measurement of body composition in participants

    Time frame: 4 weeks

    lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 4 weeks

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Biostimulants Application to Vegetables

Acronym: SwE4WEEKS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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