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Completed

NCT Number: NCT05971017

Health Effects of Biostimulated Lettuce in Human

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Control group

Dietary Supplement

Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days

Other names: Placebo Comparator

Biostimulated group

Dietary Supplement

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 names: Intervention group

Primary outcomes

  1. hepatic metabolism

    Time frame: 15 days

    AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days

  2. iron metabolism

    Time frame: 15 days

    ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days

  3. Lipid metabolism

    Time frame: 15 days

    triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days

  4. Glucose metabolism

    Time frame: 15 days

    insulin, glucose will be measured in serum will be assessed at baseline and after 15 days

  5. Gastrointestinal peptides and lipid hormones

    Time frame: 15 days

    Plasma concentrations of Gastrointestinal peptides (GLP-1, GLP-2, GIP, PYY, Ghrelin) and lipid hormones (leptin, resistin, adiponectin) will be assessed at baseline and after and after 15 days.

  6. Serum bone remodelling markers

    Time frame: 15 days

    PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.

  7. Serum bone matabolism markers

    Time frame: 15 days

    bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.

  8. body mass index (BMI)

    Time frame: 15 days

    Weight (Kg) Height (m) BMI (kg/m2)

Secondary outcomes

  1. body composition

    Time frame: 15 days

    lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population

Acronym: NUTRIWEED23

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

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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