Health Effects of Biostimulated Lettuce in Human

NCT05971017 | Completed

• 1 other identifier: Weed2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• hepatic metabolism

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

  15 days

• iron metabolism

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

  15 days

• Lipid metabolism

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

  15 days

• Glucose metabolism

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

  15 days

• Gastrointestinal peptides and lipid hormones

  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.

  15 days

• Serum bone remodelling markers

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

  15 days

• Serum bone matabolism markers

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

  15 days

• body mass index (BMI)

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

  15 days

Secondary Outcomes (1)

• body composition

  15 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Biostimulated Group

EXPERIMENTAL

experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.

Dietary Supplement: Biostimulated group

Interventions

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

Also known as: Placebo Comparator

Control group

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

Also known as: Intervention group

Biostimulated Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

NABbio, STEBICEF department

Palermo, 90128, Italy

Location

MeSH Terms

Conditions

Malnutrition; Bone Resorption; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Fatty Liver

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sara Baldassano Professor, PhD

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: control group, biostimulated group

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 2, 2023
• Study Start: March 1, 2023
• Primary Completion: May 2, 2023
• Study Completion: July 9, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)