Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Glucose metabolism
研究概览
简要总结
The aim of the project is to study the influence of biostimulate crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.
详细描述
The aim of the project is to study the influence of biostimulated crops on a healthy population in order to assess influence on hematological parameters and specific metabolism (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find out micronutrient presence in urine and serum in order to evaluate vegetables as carrier. The use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop yield and product quality, which have come under the scope of intensive research.
The present project aims to investigate the benefits of biostimulated lettuce in a cohort of healthy individuals. For biostimulation are used organic and inorganic compounds or microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance to stress. Participants will be fed with differently biostimulated lettuces to study the influence on hematological parameters.
The healthy group will eat 100 gr of Lettuce and 100 gr of biostimulated lettuce and will be collect plasma and urine samples after 15 days. 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, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK, leptin, resistin).
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
- Single (Participant)
盲法说明
Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Caucasian
- •age: 18-90 years
- •currently injury free
- •Body mass index between 18.5 and 28 kg/m2
排除标准
- •Exclusion Criteria:
- •bone fracture within the previous year
- •use of medication or suffering from any condition known to affect bone, lipid, glucose, iron metabolism
- •pregnancy
- •breastfeeding
- •current smokers
结局指标
主要结局
Glucose metabolism
时间窗: 15 days
insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
Serum bone matabolism markers
时间窗: 15 days
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
body mass index (BMI)
时间窗: 15 days
Weight (Kg) Height (m) BMI (kg/m2)
hepatic metabolism
时间窗: 15 days
AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
iron metabolism
时间窗: 15 days
ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
Lipid metabolism
时间窗: 15 days
triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
Gastrointestinal peptides and lipid hormones
时间窗: 15 days
Plasma concentrations of Gastrointestinal peptides (GLP-1, GLP-2, GIP, PYY, Ghrelin) and lipid hormones (leptin, resistin, adiponectin) will be assessed at baseline and after and after 15 days.
Serum bone remodelling markers
时间窗: 15 days
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.
次要结局
- body composition(15 days)
研究者
Sara Baldassano
PROFESSOR
University of Palermo
