Food AllergyDATTERINONCT05232890
Hydroponic Cultivation in Systemic Nickel Allergy Syndrome
A study testing Datterino tomato purée from hydroponic technology and Datterino tomato puree from conventional cultivation in people with Food Allergy and Food Hypersensitivity, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Oral intake of nickel (Ni) is capable of causing the onset of systemic disorders in patients with Systemic Allergy to Nickel Syndrome (SNAS), an emerging allergic condition. Given its ubiquitous age, it is not possible to completely eliminate Ni and, therefore, it is necessary to plan a low-content diet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Food Allergy, Food Hypersensitivity, Nickel Sensitivity
- What is being tested?
- Datterino tomato purée from hydroponic technology and Datterino tomato puree from conventional cultivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2021to 31 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented diagnosis of SNAS: a) history of SNAS (coexistence of typical skin symptoms and gastrointestinal symptoms); b) positive nickel sulphate patch test; c) clinical improvement of at least 70% after 4-6 weeks of low-nickel diet; d) positivity of the oral challenge test with nickel sulphate.
- Age between 18 and 65 years.
- Written informed consent to participate in the study.
- Patients who are able to participate in all study procedures and to accept and comply with all study needs throughout the study, including the availability of suitable transportation and the time required to undergo all procedures. planned visits.
Who cannot join
- Women who are pregnant or breastfeeding.
- Patients diagnosed with organic diseases capable of affecting gastrointestinal symptoms (eg celiac disease, poorly controlled diabetes, scleroderma, chronic inflammatory bowel diseases). Lactose intolerance is not an exclusion criterion if the diagnosis has been made for more than 6 months and if the patient does not report adequate symptom relief after at least 6 months of a lactose-free diet.
- Patients who have been taking systemic probiotics, antibiotics or systemic corticosteroids within the past 30 days.
- Patients who have been taking antidepressant or anxiolytic drugs for less than a month. On the other hand, patients can be enrolled who have been taking the aforementioned drugs at a stable dosage for at least one month.
- Patients who abuse coffee, tea, coca cola and with a smoking habit.
- Patients with pacemakers because they cannot be subjected to bioimpedance analysis for the assessment of body composition.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
About this study
Official title: Hydroponic Cultivation: a New Dietary Frontier in Systemic Nickel Allergy Syndrome - a Double Blind, Randomized, Controlled, Cross-over, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce
Oral intake of nickel (Ni) is capable of causing the onset of systemic disorders in patients with Systemic Allergy to Nickel Syndrome (SNAS), an emerging allergic condition. Given its ubiquitous age, it is not possible to completely eliminate Ni and, therefore, it is necessary to plan a low-content diet. However, due to various factors (such as variability of Ni concentration in the soil, individual foods, variability of dietary habits and daily menus, different intake of Ni contained in the water, different intake of kitchen utensils, simultaneous intake of other substances), a restrictive diet is difficult and socially discriminating with a strongly negative impact on the quality of life of these patients.
Hydroponic agriculture in a completely controlled, aseptic, artificial, soilless environment could be an alternative for patients suffering from SNAS with known and lower concentrations of metals than those deriving from conventional agricultural techniques, which are affected by the soil of origin and practices cultivation.
Read more
The primary outcome of the study is to evaluate the possible effects of taking tomato puree deriving from hydroponic agriculture compared to tomato puree from conventional cultivation in the subjective control of SNAS symptoms, in patients following a low-diet diet.
This is an interventional, randomized, double-blind, single-center crossover study involving a cohort of SNAS patients following a low-nickel diet for at least 4-6 weeks.
- Conditions
- Food Allergy, Food Hypersensitivity, Nickel Sensitivity
- Being tested
- Datterino tomato purée from hydroponic technology, Datterino tomato puree from conventional cultivation
- Keywords
- Systemic Nickel Allergy Syndrome, Hydroponic cultivation, Tomato, Quality of life, Intestinal permeability
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datterino tomato purée from hydroponic technologyOther
Daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle.
Datterino tomato puree from conventional cultivationOther
Daily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle.
| Study group | Role | What they receive |
|---|---|---|
| Datterino tomato purée from hydroponic technology | Experimental | 100% Italian datterino tomato purée deriving from hydroponic technology (soilless) with particular characteristics such as nickel free and zero residue. Receives: Other: Datterino tomato purée from hydroponic technology |
| Datterino tomato purée from conventional cultivation | Active comparator | 100% Italian datterino tomato purée deriving from conventional cultivation. Receives: Other: Datterino tomato puree from conventional cultivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gastrointestinal symptoms control
Average values of the scores relating to the individual SNAS symptoms as reported in the visual analogue scale (VAS) - Systemic Nickel Allergy Syndrome (SNAS) scale before and after taking each type of tomato sauce (hydroponic vs conventional).
This scale includes values from a minimum of zero to a maximum of ten. Higher scores indicate a worse outcome.
Measured: Immediately after the intervention
Secondary outcomes (8)
Change of impact on quality of life - SF-36
Difference in mean scores on quality of life questionnaire Short Form 36 Items Health Survey (SF-36) before and after each planned dietary treatment (hydroponic vs conventional tomato).
Each patient answers SF-36v2 (Italian version) questionnaire. It comprises 36-items measuring 8 dimensions of general QoL. Each question's score is coded, summed up, and transformed to a scale of 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
Measured: Change from baseline index at 12 and 26 weeks.
Change of impact on quality of life - PGWBI
Difference in mean scores on quality of life questionnaire Psychological General Well Being Index (PGWBI) before and after each planned dietary treatment (hydroponic vs conventional tomato).
PGWBI consists of 22 questions, which deal with 6 factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment. The response format is graded 1-6. This index includes values from a minimum of 0 to a maximum of 110. Higher scores indicate a better outcome.
Measured: Change from baseline index at 12 and 26 weeks.
Change of intestinal permeability
Difference in mean values of serum zonulin (a biomarker of intestinal permeability) before and after each planned dietary treatment (hydroponic vs conventional tomato puree).
Measured: Change from baseline index at 12 and 26 weeks.
Change of beta-carotene
Difference in the average values of beta-carotene [microg/dl] before and after each planned dietary treatment (hydroponic vs conventional tomato puree).
Measured: Change from baseline index at 12 and 26 weeks.
Change of Vitamin D
Difference in the average values of Vitamin D [ng/ml] before and after each planned dietary treatment (hydroponic vs conventional tomato puree).
Measured: Change from baseline index at 12 and 26 weeks.
Change of hemoglobin
Difference in the average values of hemoglobin [g/dl] before and after each planned dietary treatment (hydroponic vs conventional tomato puree).
Measured: Change from baseline index at 12 and 26 weeks.
Change of ferritin
Difference in the average values of ferritin [ng/ml] before and after each planned dietary treatment (hydroponic vs conventional tomato puree).
Measured: Change from baseline index at 12 and 26 weeks.
Change of adherence
Cross-comparison between the percentages of weekly intake [average number of days per week] of tomato puree (hydroponic tomato puree before and conventional after versus conventional tomato puree before and hydroponic after).
Measured: After 12 weeks, after 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start26 Feb 2021
- Primary completion28 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At enrollment, patients are randomized to one of the following study groups: Group A and Group B: * Treatment arm A: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle. * Treatment arm B: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720ml bottle. After this initial treatment phase, both study groups follow a 2-week wash-out period, following a low-nickel diet. At the end of the wash-out phase, the two groups cross-over. Therefore, Group A is assigned to treatment arm B, and vice versa, for a period of 12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Nucera, Catholic University of the Sacred Heart
- Investigators
- Eleonora Nucera, Prof., MD, Principal investigator, Catholic University of Sacred HeartAngela Rizzi, MD, PhD, Principal investigator, Catholic University of Sacred HeartAntonio Gasbarrini, Prof., MD, Study director, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232890
- Sponsor's protocol ID
- ID3643
- Acronym
- DATTERINO
- Status last verified
- Apr 2022
- First submitted
- 17 Nov 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroponic Cultivation: a New Dietary Frontier in Systemic Nickel Allergy Syndrome - a Double Blind, Randomized, Controlled, Cross-over, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce
- ClinicalTrials.gov ID
- NCT05232890
- Acronym / sponsor ID
- DATTERINO / ID3643
- Conditions
- Food Allergy, Food Hypersensitivity, Nickel Sensitivity
- Keywords
- Systemic Nickel Allergy Syndrome, Hydroponic cultivation, Tomato, Quality of life, Intestinal permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Feb 2022 (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.
Oral intake of nickel (Ni) is capable of causing the onset of systemic disorders in patients with Systemic Allergy to Nickel Syndrome (SNAS), an emerging allergic condition. Given its ubiquitous age, it is not possible to completely eliminate Ni and, therefore, it is necessary to plan a low-content diet. However, due to various factors (such as variability of Ni concentration in the soil, individual foods, variability of dietary habits and daily menus, different intake of Ni contained in the water, different intake of kitchen utensils, simultaneous intake of other substances), a restrictive diet is difficult and socially discriminating with a strongly negative impact on the quality of life of these patients.
Hydroponic agriculture in a completely controlled, aseptic, artificial, soilless environment could be an alternative for patients suffering from SNAS with known and lower concentrations of metals than those deriving from conventional agricultural techniques, which are affected by the soil of origin and practices cultivation.
The primary outcome of the study is to evaluate the possible effects of taking tomato puree deriving from hydroponic agriculture compared to tomato puree from conventional cultivation in the subjective control of SNAS symptoms, in patients following a low-diet diet.
This is an interventional, randomized, double-blind, single-center crossover study involving a cohort of SNAS patients following a low-nickel diet for at least 4-6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- At enrollment, patients are randomized to one of the following study groups: Group A and Group B: * Treatment arm A: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle. * Treatment arm B: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720ml bottle. After this initial treatment phase, both study groups follow a 2-week wash-out period, following a low-nickel diet. At the end of the wash-out phase, the two groups cross-over. Therefore, Group A is assigned to treatment arm B, and vice versa, for a period of 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Datterino tomato purée from hydroponic technology | Experimental | Other: Datterino tomato purée from hydroponic technology100% Italian datterino tomato purée deriving from hydroponic technology (soilless) with particular characteristics such as nickel free and zero residue. |
| Datterino tomato purée from conventional cultivation | Active comparator | Other: Datterino tomato puree from conventional cultivation100% Italian datterino tomato purée deriving from conventional cultivation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with documented diagnosis of SNAS: a) history of SNAS (coexistence of typical skin symptoms and gastrointestinal symptoms); b) positive nickel sulphate patch test; c) clinical improvement of at least 70% after 4-6 weeks of low-nickel diet; d) positivity of the oral challenge test with nickel sulphate.
- Age between 18 and 65 years.
- Written informed consent to participate in the study.
- Patients who are able to participate in all study procedures and to accept and comply with all study needs throughout the study, including the availability of suitable transportation and the time required to undergo all procedures. planned visits.
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding.
- Patients diagnosed with organic diseases capable of affecting gastrointestinal symptoms (eg celiac disease, poorly controlled diabetes, scleroderma, chronic inflammatory bowel diseases). Lactose intolerance is not an exclusion criterion if the diagnosis has been made for more than 6 months and if the patient does not report adequate symptom relief after at least 6 months of a lactose-free diet.
- Patients who have been taking systemic probiotics, antibiotics or systemic corticosteroids within the past 30 days.
- Patients who have been taking antidepressant or anxiolytic drugs for less than a month. On the other hand, patients can be enrolled who have been taking the aforementioned drugs at a stable dosage for at least one month.
- Patients who abuse coffee, tea, coca cola and with a smoking habit.
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 |
|---|---|---|
| Datterino tomato purée from hydroponic technologyDaily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle. | Other | Datterino tomato purée from hydroponic technology |
| Datterino tomato puree from conventional cultivationDaily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle. | Other | Datterino tomato purée from conventional cultivation |
Primary outcome
Change of gastrointestinal symptoms control
Time frame: Immediately after the intervention
Average values of the scores relating to the individual SNAS symptoms as reported in the visual analogue scale (VAS) - Systemic Nickel Allergy Syndrome (SNAS) scale before and after taking each type of tomato sauce (hydroponic vs conventional). This scale includes values from a minimum of zero to a maximum of ten. Higher scores indicate a worse outcome.
8 secondary outcomes
Change of impact on quality of life - SF-36
Time frame: Change from baseline index at 12 and 26 weeks.
Change of impact on quality of life - PGWBI
Time frame: Change from baseline index at 12 and 26 weeks.
Change of intestinal permeability
Time frame: Change from baseline index at 12 and 26 weeks.
Change of beta-carotene
Time frame: Change from baseline index at 12 and 26 weeks.
Change of Vitamin D
Time frame: Change from baseline index at 12 and 26 weeks.
Change of hemoglobin
Time frame: Change from baseline index at 12 and 26 weeks.
Change of ferritin
Time frame: Change from baseline index at 12 and 26 weeks.
Change of adherence
Time frame: After 12 weeks, after 26 weeks.
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 5 Apr 2022.
- 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.
Eleonora Nucera, Prof., MD principal investigator
Catholic University of Sacred Heart
Angela Rizzi, MD, PhD principal investigator
Catholic University of Sacred Heart
Antonio Gasbarrini, Prof., MD study director
Catholic University of Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Datterino tomato purée from hydroponic technology and Datterino tomato puree from conventional cultivation in people with Food Allergy and Food Hypersensitivity, run by Catholic University of the Sacred Heart 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 6 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 5 Apr 2022. 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. 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?
Change of gastrointestinal symptoms control (time frame: Immediately after the intervention). 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 5 Apr 2022.