NCT05232890: DATTERINO

Hydroponic Cultivation in Systemic Nickel Allergy Syndrome

Completed NA Last updated 5 April 2022

What this trial tests

NA trial testing Datterino tomato purée from hydroponic technology in Food Allergy in 30 participants. Completed in 31 March 2022.

Timeline

26 February 2021

Primary endpoint
28 February 2022

31 March 2022

Quick facts

Lead sponsor	Catholic University of the Sacred Heart
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	26 February 2021
Primary completion	28 February 2022
Estimated completion	31 March 2022
Sites	1 location across Italy

Drugs / interventions tested

• Datterino tomato purée from hydroponic technology
• Datterino tomato puree from conventional cultivation

Conditions studied

• Food Allergy — all drugs for Food Allergy →
• Food Hypersensitivity — all drugs for Food Hypersensitivity →
• Nickel Sensitivity — all drugs for Nickel Sensitivity →

Sponsor

Catholic University of the Sacred Heart

Who can join

Adults 18 to 65, any sex, with Food Allergy or Food Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Datterino Trial: A Double Blind, Randomized, Controlled, Crossover, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce in Systemic Nickel Allergy Syndrome.
   Rizzi A, Chini R, Porcari S, Settanni CR, et al · · 2022 · PMID 36143107 · DOI 10.3390/jcm11185459