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Health Effects of Biostimulated Lettuce in Human (NUTRIWEED23)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05971017
Recruitment Status : Completed
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
Sponsor:
Information provided by (Responsible Party):
Sara Baldassano, University of Palermo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nutrition, Healthy Dietary Deficiency Bone Resorption Glucose Metabolism Disorders Lipid Metabolism Disorder Hepatic Steatosis Dietary Supplement: Control Group Dietary Supplement: Biostimulated group Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: control group, biostimulated group
Masking: Single (Participant)
Masking Description: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
Primary Purpose: Prevention
Official Title: Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
Actual Study Start Date : March 1, 2023
Actual Primary Completion Date : May 2, 2023
Actual Study Completion Date : July 9, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)
 Dietary Supplement: Control Group
Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days
Other Name: Placebo Comparator
Experimental: Biostimulated Group
experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
 Dietary Supplement: Biostimulated group
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 Name: Intervention group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05971017


Locations
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Italy
NABbio, STEBICEF department
Palermo, Italy, 90128
Sponsors and Collaborators
University of Palermo
Investigators
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Principal Investigator: Sara Baldassano Professor, PhD University of Palermo
  Study Documents (Full-Text)

Documents provided by Sara Baldassano, University of Palermo:
Study Protocol and Statistical Analysis Plan  [PDF] July 12, 2023

More Information
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Additional Information:

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Responsible Party: Sara Baldassano, PROFESSOR, University of Palermo
ClinicalTrials.gov Identifier: NCT05971017    
Other Study ID Numbers: Weed2023
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because is forbidden by the Italian Low

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Resorption
Fatty Liver
Metabolic Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Malnutrition
 Liver Diseases
Digestive System Diseases
Bone Diseases
Musculoskeletal Diseases
Nutrition Disorders