Biostimulants Application to Vegetables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Measurement of minerals concentration in participants
研究概览
简要总结
Biostimulants application to vegetables is a useful agronomic approach to reduce the use of pesticides and to improve crop yield and quality by a naturally functionalizing process. The aim of the study is to verify the effects of a nutritional intervention with lettuce Biostimulated by application of seaweed extracts derived from Ecklonia maxima (SwE) in a healthy population in order to assess influence on specific essential minerals like calcium, potassium iron, magnesium, phosphorous (Primary outcome) and metabolisms like glucose, lipid, iron homeostasis (Secondary outcome).
详细描述
The present project aims to investigate the benefits of biostimulants lettuce in a cohort of healthy individuals. Biostimulants are organic and inorganic compounds or microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance to stress. Seaweed extract treatment seems to enhance mineral concentration in crops. Participants will be fed with biostimulated lettuce or a tablet of iron daily in order to study the influence on hematological parameters.
A cohort of healthy subjects will be divided into a control group, receiving control lettuce, lettuce SwE group, receiving biostimulated lettuce and iron tablet group receiving iron bisglycinate (30 mg) supplement in tablet for a total of 4 weeks. Blood samples will be collected in specific tubes before (baseline) and after the nutritional intervention (T2). The group will eat 100 grams of Lettuce (control group) and 100 grams of SwE Biostimulated lettuce (intervention group lettuce) for 4 weeks (100 grams/daily) or a tablet of iron (intervention group iron tablet) and collect blood samples (serum and plasma) baseline, before starting the nutritional intervention and after 4 weeks (T2).
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, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Ferritin, Iron, transferrin, Magnesium, Calcium, Potassium, Phosphate, Potassium.
Statistical analysis plan:
Student t tests will be used to compare the baseline characteristics of the groups. Changes between baseline and follow-up will be analyzed by one-way ANOVA followed by Sidak post test. A P < 0.05 will be considered to be statistically significant by using appropriate software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 - 70 years
- •Italian Ethnicity
- •Body mass index between 18.5 and 28.5 kg/m2
- •Clinically Healthy
排除标准
- •Chronic disease
- •Use of drugs
- •Pregnancy
- •Exogenous hormones
- •Breastfeeding
- •Use of supplements
- •sensitivity to lettuce
结局指标
主要结局
Measurement of minerals concentration in participants
时间窗: 4 weeks
Calcium (mg/dL), Phosphate (mg/dL), Magnesium (mg/dL) will be assessed in serum at baseline and after 4 weeks.
Measurement of iron concentration in participants
时间窗: 4 weeks
Iron (μg/dL) will be assessed in serum at baseline and after 4 weeks.
Measurement of Potassium concentration in participants
时间窗: 4 weeks
Potassium (mmol/L) will be assessed in serum at baseline and after 4 weeks.
次要结局
- Measurement of ferritin in participants(4 weeks)
- Measurement of lipid metabolism markers in participants(4 weeks)
- Measurement of insulin in participants(4 weeks)
- Measurement of transferrin in participants(4 weeks)
- Measurement of % saturation of transferrin in participants(4 weeks)
- Measurement of glucose in participants(4 weeks)
研究者
Sara Baldassano
Professor
University of Palermo