Intake of a Polysaccharides Mix (LibraMedR) in Obese Children. 1. Postprandial Effects on Metabolism, Hormones and Satiety; 2. Effects on Body Fat, Glucide and Fat Metabolism After a 60-day Treatment.
试验速览
- 阶段
- 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Area under the curve of plasma glucose.
研究概览
简要总结
AIMS
Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and metabolic profile.
Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic profile after oral glucose load.
SUBJECTS
Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2.
Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial.
METHODS
Experimental protocol phase 1
Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken at 30-minute intervals for the first two hours and 60 minutes for the following two hours, for the determination of metabolites and hormones for a total of 4 hours. The level of satiety will be quantified through a visual analog scale.
Experimental protocol phase 2
Based on the results of the OGTT performed in recruitment phase, children will be divided into two groups: group A, children with blood glucose 2 hours after oral load higher than the median and group B, children with blood glucose 2 hours after oral load below the median.
The children of group A will be randomly assigned to LibramedR treatment or placebo for 60 days, after which they will repeat Anthropometric measurements, bioelectrical impedance, OGTT and blood chemistry. They will also repeat dietary and sport anamnesis .
During the 60 days, the children of both groups will receive the same dietary treatment consisting of a low-calorie and balanced diet, and recommendations to practice more sport.
Every 15 days a research assistant will contact the families to reinforce treatment adherence.
EXPECTED RESULTS
Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose, insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo treatment;
Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose and insulin secretion after OGTT compared to placebo treatment.
详细描述
INTRODUCTION
The postprandial phase has a fundamental role in metabolic regulation. In fact, being exposed to high levels of substrates such as glucose and fatty acids after food intake tends to increase the risk of cardiovascular disease. This is even more relevant in reference to the amount of hours in which the subject is in postprandial condition and therefore exposed to high concentrated substrates. Food intake, moreover, regulates gastrointestinal secretion of hormones which help balance between hunger and satiety, by regulating nutrients supply and peripheral substrate consumption.
An obese subject, due to excessive body fat and of its accumulation, presents high insulin, glucose and triglyceride blood levels, and blood pressure which increase the risk of cardiovascular disease. Since the body is for most of the time in postprandial phase, substrate and hormone containment a few hours after food intake helps limit exposition to cardiovascular risks and potential metabolic and vascular damage.
On equal food and energy intake, a meal's composition has great influence over postprandial and hormonal metabolic profiles. A high lipid/carbohydrate ratio meal, for instance, produces higher postprandial triglycerides and GLP-1 secretion, and lower glucose and insulin levels than an isocaloric, isoproteic meal with low lipid/carbohydrate ratio. The intake of polysaccharides macromolecules produces an endoluminal gel that reduces and delays the absorption of intestinal nutrients, especially glucose and lipids. The intake of soluble fibre is associated to a better glycaemic profile and postprandial lipemia.
At present, it is not known whether the intake of macromolecules such as Policaptil Gel RetardR polysaccharides (LibramedR) before the meal affects the metabolic response (substrate oxidation, hormonal and circulating nutrients variation) and the satiating effect compared to the same meal after taking placebo, and could therefore help to reduce postprandial cardiovascular risks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age, ethnicity (Caucasians), obesity (BMI> cut-off of BMI for age and gender indicative of obesity, defined by the International Obesity Task Force), acceptance to take part in the study.
- •Exclusion criteria:
- •birth defects, genetic disorders, chronic diseases, obesity secondary to chronic intake of drugs or endocrine causes or genetic therapy for obesity already in progress.
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial.
干预措施: Placebo (Drug)
Libramed
Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial.
干预措施: Libramed (Drug)
结局指标
主要结局
Area under the curve of plasma glucose.
时间窗: Meal test 4-hours frame time
Both placebo and intervention subjects will undergo a 4 hours lasting meal test during which blood glucose will be measured periodically and the area under the curve of plasma glucose during the test period will be then calculated for each subject.
次要结局
未报告次要终点
研究者
Claudio Maffeis
MD
Azienda Ospedaliera Universitaria Integrata Verona