Dietary Deficiency, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Nutrition, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTiron supplementation
The iron tablet group received iron supplementation (30 mg, 1 tablet/day of iron) for 4 weeks
DIETARY_SUPPLEMENTBiostimulated lettuce supplementation
the intervention group SwE lettuce group received lettuce biostimulated with Ecklonia Maxima algae (SwE lettuce, 100 grams/day) daily for 4 weeks
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of minerals concentration in participants | 4 weeks | Calcium (mg/dL), Phosphate (mg/dL), Magnesium (mg/dL) will be assessed in serum at baseline and after 4 weeks. |
| Measurement of Potassium concentration in participants | 4 weeks | Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks. |
| Measurement of iron concentration in participants | 4 weeks | Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of insulin in participants | 4 weeks | insulin (mUI/L) will be measured in serum at baseline and after 4 weeks |
| Measurement of ferritin in participants | 4 weeks | Ferritin (ng/dL) will be measured in serum at baseline and after 4 weeks |
| Measurement of lipid metabolism markers in participants | 4 weeks | triglicerises, HDL, LDL, cholesterol (in mg/dL) will be measured in serum at baseline and after 4 weeks |
| Measurement of transferrin in participants | 4 weeks | transferrin (mg/dL) will be measured in serum at baseline and after 4 weeks |
| Measurement of % saturation of transferrin in participants | 4 weeks | % saturation of transferrin will be measured in serum at baseline and after 4 weeks |
| Measurement of glucose in participants | 4 weeks | glucose (mg/dL) will be measured in serum at baseline and after 4 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of body mass index (BMI) in participants | 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). |
| Measurement of Height in participants | 4 weeks | Height (meters) will be assessed at baseline and after 4 weeks |
| Measurement of body composition in participants | 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 |
| Measurement of body weight in participants | 4 weeks | Body weight (kg) will be assessed at baseline and after 4 weeks |
Countries
Italy
Outcome results
None listed