Effects of a Supplementation With Zinc and Myo-inositol in Paediatric Obesity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in HOMA-IR index
研究概览
简要总结
Myoinositol (MI) and D-chiro inositol (DCI) are isomeric forms of inositol that were found to have insulin-like properties, acting as second messengers in the insulin intracellular pathway; both of these molecules are involved in the increasing insulin sensitivity of different tissues to improve metabolic and ovulatory functions. Myoinositol is the predominant form that can be found in nature and food.
Inositol has been mainly used as a supplement in treating several pathologies such as polycystic ovary syndrome (PCOS), metabolic syndrome, type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). In the case of GDM, a condition defined as a glucose impairment first detected in pregnancy, a preventive role of inositol for GDM onset was recognized. In addition, inositol has been studied as a therapeutic option for the treatment of GDM and T2DM. The main effect of inositol is decreasing the level of insulin resistance. Consequently, a potential role of inositol as a treatment option could be hypothesized for other conditions typically characterized by insulin resistance like metabolic syndrome and obesity.
Zinc also plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Several human studies have demonstrated that Zinc supplementation reduces total cholesterol, LDL cholesterol and triglycerides, in addition to increasing the HDL cholesterol levels. Studies have shown that diabetes is accompanied by hypozincemia and high levels of Zinc in urine. In addition Zinc is also an integral part of key anti-oxidant enzymes and Zinc deficiency impairs their synthesis, resulting in increased oxidative stress.
A supplementation with Myo-Inositol and Zinc could represent a valid strategy in paediatric obesity in addiction to a standard approach. The purpose of our study is to evaluate the supplementation of Myo-inositol and Zinc in the treatment of paediatric obesity.
详细描述
Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 60 subjects of both sexes, with pubertal stage ≥ 3 according to the Tanner stage, obese according to the IOTF criteria (International Obesity Task Force), diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).
Intervention: Patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group (group "active") will receive the supplementation with Myoinositol and Zinc (active product) and the other group (group "Placebo") will receive a placebo for a total of 3 months of treatment.
Dietary restriction: The standard diet will be distributed with 55-60% of carbohydrates, 25-30% lipids and 15% proteins, and will be performed in accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Italian Society of Human Nutrition, 2014), inspired to Mediterranean pyramid.
Physical activity: all subjects will receive general recommendations about performing physical activity.
Randomization: Participants will be randomly assigned in a 1:1 to active intervention Group (Active Group) or Placebo Group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sexes
- •between 6 and 18 years of age
- •obese, according to the IOTF criteria (Cole TJ et al., 2000)
- •pubertal stage ≥ 3 according to the Tanner stage (Tanner et al., 1961)
- •HOMA-IR > 2,5 or insulin > 15 µU/ml
- •Serum Zinc level in the range of normality or under the normal levels.
排除标准
- •Adverse reactions to the product or component of the product (allergies...)
- •Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-Biedl syndrome...), endocrinological obesity (Cushing syndrome, hypothyroidism)
- •Chronic diseases, hepatic or gastroenterological diseases
- •Medical treatment for chronic diseases
- •Supplementation with inositol-like products or supplements containing Zinc and Inositol.
研究组 & 干预措施
Active group - Zinc and Myo-inositol
This arm will receive a supplementation with Zinc and Myo-inositol once a day.
干预措施: Zinc (Dietary Supplement)
Active group - Zinc and Myo-inositol
This arm will receive a supplementation with Zinc and Myo-inositol once a day.
干预措施: Myoinositol (Drug)
Placebo group
This arm will receive a supplementation with a same product equal to the active product but without Zinc and Myo-inositol inside.
干预措施: Placebos (Drug)
结局指标
主要结局
Change in HOMA-IR index
时间窗: Change from baseline HOMA-IR (V0) at 3 months (V1).
Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a variation of HOMA-IR index. Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.
次要结局
- Change in glucose level during oral glucose tolerance test (OGTT)(Change from Baseline OGTT (V0) at 3 months (V1))
- Metabolic control: Improvement of metabolic risk factors(Change from baseline lipid profile, insulin, leptin, adiponectin, GLP1 (V0) at 3 months (V1))
研究者
Simonetta Bellone
Assoc. Professor
Azienda Ospedaliero Universitaria Maggiore della Carita