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Health Effects of Biostimulated Lettuce in Human (NUTRIWEED23)

U

University of Palermo

Status

Completed

Conditions

Lipid Metabolism Disorder
Glucose Metabolism Disorders
Dietary Deficiency
Hepatic Steatosis
Nutrition, Healthy
Bone Resorption

Treatments

Dietary Supplement: Control Group
Dietary Supplement: Biostimulated group

Study type

Interventional

Funder types

Other

Identifiers

NCT05971017
Weed2023

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)
Treatment:
Dietary Supplement: Control Group
Biostimulated Group
Experimental group
Description:
experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
Treatment:
Dietary Supplement: Biostimulated group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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