Analysis of the Potential Health Effects of Saline Eustress in Plant Food
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- blood markers
研究概览
简要总结
The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.
详细描述
Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 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, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.
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
- Double (Participant, Investigator)
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-65 years
- •currently injury free
- •Body mass index between 18.5 and 28 kg/m2
排除标准
- •Use of vitamins and minerals supplements,
- •use of medications
- •Presence of metabolic or chronic disease
- •Pregnancy, breastfeeding condition,
结局指标
主要结局
blood markers
时间窗: 12 days
Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
% saturation of transferrin
时间窗: 12 days
% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
Potassium
时间窗: 12 days
Potassium (mmol/L) will be assessed at baseline and after 12 days.
Iron
时间窗: 12 days
iron (μg/dL) will be assessed in serum at baseline and after 12 days.
Ferritin
时间窗: 12 days
ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
Bone metabolism markers
时间窗: 12 days
Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
transferrin
时间窗: 12 days
transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
markers of lipid metabolism
时间窗: 12 days
triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Insulin
时间窗: 12 days
insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
Glucose
时间窗: 12 days
Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
Vitamin D
时间窗: 12 days
Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
markers of hepatic metabolism
时间窗: 12 days
Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.
anthropometric measurement
时间窗: 12 days
weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m\^2).
Bone remodelling markers
时间窗: 12 days
markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.
Total protein (TP) and Albumin
时间窗: 12 days
Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
次要结局
- body composition(12 days)
研究者
Sara Baldassano
Professor
University of Palermo