Healthy DietESEPFNCT06002672
Effects of Saline Eustress in Plant Food (ESEPF)
A study testing Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce. in people with Healthy Diet, run by University of Palermo at 1 site in Italy.
Trial summary
The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 28 Jun 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Italian
- age: 18-65 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Who cannot join
- Use of vitamins and minerals supplements,
- use of medications
- Presence of metabolic or chronic disease
- Pregnancy, breastfeeding condition,
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Potential Health Effects of Saline Eustress in Plant Food
The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.
Read the detailed description
Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 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, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.
- Conditions
- Healthy Diet
- Being tested
- Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time)., Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).Dietary supplement
Also called control lettuce
Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.Dietary supplement
Also called Eustress Intervention group
100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | group that consumed control lettuce Receives: Dietary Supplement: Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time). |
| Intervention | Active comparator | group that consumed eustress lettuce Receives: Dietary Supplement: Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce. |
What is being measured
The primary outcome is the main question the study is designed to answer.
anthropometric measurement
weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m^2).
Measured: 12 days
Bone metabolism markers
Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
Measured: 12 days
Vitamin D
Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
Measured: 12 days
blood markers
Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
Measured: 12 days
Potassium
Potassium (mmol/L) will be assessed at baseline and after 12 days.
Measured: 12 days
Bone remodelling markers
markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.
Measured: 12 days
Iron
iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Measured: 12 days
Ferritin
ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
Measured: 12 days
transferrin
transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
Measured: 12 days
% saturation of transferrin
% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
Measured: 12 days
markers of lipid metabolism
triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Measured: 12 days
Insulin
insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Measured: 12 days
Glucose
Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Measured: 12 days
markers of hepatic metabolism
Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.
Measured: 12 days
Total protein (TP) and Albumin
Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
Measured: 12 days
Secondary outcomes (1)
body composition
lean mass as percent of body weight and fat mass as percent of body weight will be will be assessed at baseline and after 12 days
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Mar 2021
- Primary completion1 Apr 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies 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 vs intervention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002672
- Sponsor's protocol ID
- Plant_Food_2021
- Acronym
- ESEPF
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrantelli V, Vasto S, Alongi A, Sabatino L, Baldassano D, Caldarella R, Gagliano R, Di Rosa L, Consentino BB, Vultaggio L, Baldassano S. Boosting plant food polyphenol concentration by saline eustress as supplement strategies for the prevention of metabolic syndrome: an example of randomized interventional trial in the adult population. Front Nutr. 2023 Dec 22;10:1288064. doi: 10.3389/fnut.2023.1288064. eCollection 2023.
PubMed 38196756
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Potential Health Effects of Saline Eustress in Plant Food
- ClinicalTrials.gov ID
- NCT06002672
- Acronym / sponsor ID
- ESEPF / Plant_Food_2021
- Conditions
- Healthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 21 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 if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.
Detailed description
Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 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, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- control vs intervention
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).group that consumed control lettuce |
| Intervention | Active comparator | Dietary Supplement: Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.group that consumed eustress lettuce |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Italian
- age: 18-65 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Key exclusion criteria (5 listed)
- Use of vitamins and minerals supplements,
- use of medications
- Presence of metabolic or chronic disease
- Pregnancy, breastfeeding condition,
- 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 |
|---|---|---|
| Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).Also: control lettuceLettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day | Dietary supplement | Control |
| Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.Also: Eustress Intervention group100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days | Dietary supplement | Intervention |
Primary outcome
anthropometric measurement
Time frame: 12 days
weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m^2).
Bone metabolism markers
Time frame: 12 days
Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
Vitamin D
Time frame: 12 days
Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
blood markers
Time frame: 12 days
Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
Potassium
Time frame: 12 days
Potassium (mmol/L) will be assessed at baseline and after 12 days.
Bone remodelling markers
Time frame: 12 days
markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.
Iron
Time frame: 12 days
iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Ferritin
Time frame: 12 days
ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
transferrin
Time frame: 12 days
transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
% saturation of transferrin
Time frame: 12 days
% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
markers of lipid metabolism
Time frame: 12 days
triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Insulin
Time frame: 12 days
insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Glucose
Time frame: 12 days
Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
markers of hepatic metabolism
Time frame: 12 days
Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.
Total protein (TP) and Albumin
Time frame: 12 days
Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
1 secondary outcome
body composition
Time frame: 12 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 21 Aug 2023.
- Derived from this study: PubMed 38196756Ferrantelli V, Vasto S, Alongi A, Sabatino L, Baldassano D, Caldarella R, Gagliano R, Di Rosa L, Consentino BB, Vultaggio L, Baldassano S. Boosting plant food polyphenol concentration by saline eustress as supplement strategies for the prevention of metabolic syndrome: an example of randomized interventional trial in the adult population. Front Nutr. 2023 Dec 22;10:1288064. doi: 10.3389/fnut.2023.1288064. eCollection 2023.
- Individual participant dataSharing planned: No
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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 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 Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce. in people with Healthy Diet, 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 21 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?
anthropometric measurement (time frame: 12 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002672, which also lists 1 linked publication.
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 21 Aug 2023.