Health Effects of Biostimulated Lettuce in Human
Condition: Nutrition, Healthy; Dietary Deficiency; Bone Resorption; Glucose Metabolism Disorders; Lipid Metabolism Disorder; Hepatic Steatosis
MeSH terms: Bone Resorption; Fatty Liver; Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Malnutrition
Study type: Interventional

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).
    

Intervention name(s): Control Group; Biostimulated group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days; Intervention biostimulated group 100gr of biostimulated lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 15 days
Other intervention name(s): Placebo Comparator; Intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group, biostimulated group
Masking: Single (Participant)
Primary purpose: Prevention