NCT05232890

Hydroponic Cultivation in Systemic Nickel Allergy Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Food Allergy
• Food Hypersensitivity
• Nickel Sensitivity

Interventions

Type	Name	Description
OTHER	Datterino tomato purée from hydroponic technology	Daily 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 puree from conventional cultivation	Daily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle.

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-02-28
• Completion: 2022-03-31
• First posted: 2022-02-10
• Last updated: 2022-04-05

Locations

1 site across 1 country: Italy