Clinical trial NCT05971017: Health Effects of Biostimulated Lettuce in Human
Official title: Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Dietary Deficiency
Bone Resorption
Glucose Metabolism Disorders
Lipid Metabolism Disorder
Hepatic Steatosis
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group, biostimulated group
Primary purpose: PREVENTION

Brief summary: The aim of the project is to study the influence of biostimulate crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.

Detailed description: The aim of the project is to study the influence of biostimulated crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum in order to evaluate vegetables as carrier. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.

The present project aims to investigate the benefits of biostimulated lettuce in a cohort of healthy individuals. For biostimulation are used organic and inorganic compounds or microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance to stress. Participants will be fed with differently biostimulated lettuces to study the influence on hematological parameters.

The healthy group will eat 100 gr of Lettuce and 100 gr of biostimulated lettuce and will be collect plasma and urine samples after 15 days. 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, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK, leptin, resistin).

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  * Caucasian
  * age: 18-90 years
  * currently injury free
  * Body mass index between 18.5 and 28 kg/m2

Exclusion Criteria:

Exclusion Criteria:

* bone fracture within the previous year
* use of medication or suffering from any condition known to affect bone, lipid, glucose, iron metabolism
* pregnancy
* breastfeeding
* current smokers

Primary outcomes:
measure: hepatic metabolism
timeFrame: 15 days
measure: iron metabolism
timeFrame: 15 days
measure: Lipid metabolism
timeFrame: 15 days
measure: Glucose metabolism
timeFrame: 15 days
measure: Gastrointestinal peptides and lipid hormones
timeFrame: 15 days
measure: Serum bone remodelling markers
timeFrame: 15 days
measure: Serum bone matabolism markers
timeFrame: 15 days
measure: body mass index (BMI)
timeFrame: 15 days
Secondary outcomes:
measure: body composition
timeFrame: 15 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: NABbio, STEBICEF department
Study officials:
affiliation: University of Palermo
name: Sara Baldassano Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: