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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of gastrointestinal symptoms control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study product and the comparator product are provided in identical packaging, the labeling shows the randomization number which, however, only the Outcomes Assessor is able to refer to the type of treatment assigned. The organoleptic characteristics of the two products are as similar as possible. The instructions given to patients regarding the preparation and consumption of the products are the same for both products.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of gastrointestinal symptoms control
时间窗: 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.
次要结局
- Change of impact on quality of life - SF-36(Change from baseline index at 12 and 26 weeks.)
- Change of impact on quality of life - PGWBI(Change from baseline index at 12 and 26 weeks.)
- Change of ferritin(Change from baseline index at 12 and 26 weeks.)
- Change of intestinal permeability(Change from baseline index at 12 and 26 weeks.)
- Change of Vitamin D(Change from baseline index at 12 and 26 weeks.)
- Change of beta-carotene(Change from baseline index at 12 and 26 weeks.)
- Change of hemoglobin(Change from baseline index at 12 and 26 weeks.)
- Change of adherence(After 12 weeks, after 26 weeks.)
研究者
Eleonora Nucera
Head of Allergy Unit
Catholic University of the Sacred Heart