Nutrition, HealthyNUTRIWEED23NCT05971017
Health Effects of Biostimulated Lettuce in Human
A study testing Biostimulated group in people with Nutrition, Healthy and Dietary Deficiency, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Dietary Deficiency, Bone Resorption
- What is being tested?
- Biostimulated group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 9 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian
- age: 18-90 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
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.
Read the 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).
- Conditions
- Nutrition, Healthy, Dietary Deficiency, Bone Resorption, Glucose Metabolism Disorders, Lipid Metabolism Disorder, Hepatic Steatosis
- Being tested
- Control Group, Biostimulated group
- Medical subject headings
- Malnutrition, Bone Resorption, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDietary supplement
Also called Placebo Comparator
Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days
Biostimulated groupDietary supplement
Also called Intervention 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Control Group |
| Biostimulated Group | Experimental | experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce. Receives: Dietary Supplement: Biostimulated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic metabolism
AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
Measured: 15 days
iron metabolism
ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
Measured: 15 days
Lipid metabolism
triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Measured: 15 days
Glucose metabolism
insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
Measured: 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.
Measured: 15 days
Serum bone remodelling markers
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.
Measured: 15 days
Serum bone matabolism markers
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
Measured: 15 days
body mass index (BMI)
Weight (Kg) Height (m) BMI (kg/m2)
Measured: 15 days
Secondary outcomes (1)
body composition
lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Mar 2023
- Primary completion2 May 2023
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group, biostimulated group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Baldassano, University of Palermo
- Investigators
- Sara Baldassano Professor, PhD, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971017
- Sponsor's protocol ID
- Weed2023
- Acronym
- NUTRIWEED23
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because is forbidden by the Italian Low
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
- ClinicalTrials.gov ID
- NCT05971017
- Acronym / sponsor ID
- NUTRIWEED23 / Weed2023
- Conditions
- Nutrition, Healthy, Dietary Deficiency, Bone Resorption, Glucose Metabolism Disorders, Lipid Metabolism Disorder, Hepatic Steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- control group, biostimulated group
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Control GroupTo the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time) |
| Biostimulated Group | Experimental | Dietary Supplement: Biostimulated groupexperimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupAlso: Placebo ComparatorLettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days | Dietary supplement | Control group |
| Biostimulated groupAlso: Intervention groupIntervention 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 | Dietary supplement | Biostimulated Group |
Primary outcome
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
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
Lipid metabolism
Time frame: 15 days
triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Glucose metabolism
Time frame: 15 days
insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
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.
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.
Serum bone matabolism markers
Time frame: 15 days
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
body mass index (BMI)
Time frame: 15 days
Weight (Kg) Height (m) BMI (kg/m2)
1 secondary outcome
body composition
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No. Because is forbidden by the Italian Low
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Baldassano Professor, PhD principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biostimulated group in people with Nutrition, Healthy and Dietary Deficiency, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic metabolism (time frame: 15 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.