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临床试验/NCT03870984
NCT03870984终止不适用

Efficacy of Walnuts and Hazelnuts on the Modification of the Lipid Content of Erythrocyte Membranes in Obese Children. A Randomised Controlled Trial.

Universita di Verona2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
8
试验地点
2
主要终点
ALA change

研究概览

简要总结

Obesity is a problem of ever-growing importance, especially in industrialized countries, both in adults and in the pediatric population. Children and obese adolescents, like adults, have an increased risk, compared with normal-weight peers, to develop metabolic syndrome and atherosclerotic disease, pathophysiological basis of cardiovascular events. Alteration of the elastic properties of the arteries has been described previously in obese children and adolescents and is considered an initial marker of atherosclerotic vascular damage. The determination of the indices of arterial stiffness (PWV, Pulse Wave Velocity; AI, Augmentation Index, SI, Stiffness Index) is possible through techniques currently used for the determination of vascular function even in children.

Nuts and hazelnuts are rich in potentially beneficial substances including unsaturated fatty acids, especially omega-6 (present in both) and omega-3 (present only in nuts), Several clinical trials have already shown in adults a potential beneficial effect of the addition of different types of nuts (walnuts, hazelnuts, cashews, pistachios, etc.) on the characteristics of the metabolic syndrome also through their possible antioxidant effect and vasoactive. In children, some epidemiological studies have associated with a higher consumption of nuts reduced risk of hypertension, dyslipidemia, obesity and fasting glucose. The study will be conducted with a randomized design with two arms in parallel with blinded operator. The main objective of this study is to assess the efficacy of 15 grams of nuts and 15 grams of nuts a day in addition to a low calorie diet on the content of erythrocyte membranes of alpha-linolenic acid three months after the beginning of the trial in a group of obese children. Secondary objectives are to evaluate the efficacy of walnuts and hazelnuts in improving the systolic and/or diastolic blood pressure values, lipid profile, glucose and fasting insulin, vascular function.

详细描述

Obesity is a problem of ever-growing importance, especially in industrialized countries, widespread both in adults and in the pediatric population.

Children and obese adolescents, like adults, have an increased risk, compared with normal-weight peers, to develop high blood pressure, insulin resistance, diabetes, hyperlipidemia, fatty liver disease and the resulting long-term complications. This cluster of metabolic and hemodynamic risk factors, which is known as metabolic syndrome, greatly increases the risk of cardiovascular events in adults. Cardiovascular disease is the leading cause of mortality and morbidity in developed countries and are becoming even in developing countries. Atherosclerotic disease is the pathophysiological basis of cardiovascular events. Atherosclerosis is a multifactorial disease whose early stages of subclinical damage are documented much earlier in cardiovascular events with non-invasive tests. The determination of the indices of arterial stiffness (PWV, Pulse Wave Velocity; AI, Augmentation Index, SI, Stiffness Index) is possible through techniques currently used for the determination of vascular function even in children. The alteration of the elastic properties of the arteries has been described previously in obese children and adolescents and is considered initial marker atherosclerotic vascular damage. Fats particularly saturated fats, without adequate intake of polyunsaturated fat, may facilitate the development of obesity.

The consumption of some specific foods including dried fruit (in a broad sense including walnuts, hazelnuts, almonds, cashews, etc.) within a reduced calorie diet is considered to be a promising approach in the prevention and care of the different components of the metabolic syndrome. The nuts and hazelnuts are rich in potentially beneficial substances including unsaturated fatty acids, especially omega-6 (present in both) and omega-3 (present only in nuts), L-arginine, fiber, minerals, vitamin E, fitosetrols and polyphenols.

Several clinical trials have already shown in adults a potential beneficial effect of the addition of different types of nuts (walnuts, hazelnuts, cashews, pistachios, etc.) on the characteristics of the metabolic syndrome also through their possible antioxidant and vasoactive effect .

In children, some epidemiological studies have associated a higher consumption of nuts with reduced risk of hypertension, dyslipidemia, obesity and fasting glucose alteration.

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, Care Provider, Investigator)

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • obese subjects (BMI ≥ 95th percentile for age and sex; reference tables for WHO BMI);
  • Aged between 6 and 17 years;
  • Signature applied in the informed consent by both parents and consent of the child

排除标准

  • chronic liver diseases (hepatitis, cirrhosis).
  • Chronic renal failure (serum creatinine> 1.2 mg / dL).
  • Malignancies.
  • Diabetes (fasting blood glucose ≥ 126 mg / dl or therapy with oral hypoglycemic drugs or insulin).
  • cholesterol-lowering or antihypertensive terapy.
  • Notes allergies to nuts or hazelnuts or food intolerance to nuts and/or hazelnuts.
  • Treatment of less than 6 weeks with any medication which can interfere with fecal microbiota (particularly antibiotics or laxatives).

结局指标

主要结局

ALA change

时间窗: baseline compared to post-treatment (ie, after 3 months of treatment)

Primary outcome is to compare percentage of fatty acids in erythrocyte membranes (in particular alpha-linolenic acid, ALA) with the content of other membrane-bound fatty acids. It will be compared in the two groups the ALA delta (delta%) between measurement at baseline compared to post-treatment (ie, after 3 months of treatment).

次要结局

  • triglycerides change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • carotid distensibility (cDC) change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • plasma EETs change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • plasma DHETs change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • urine 20-HETE change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • MICROBIOTA change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • HDL-cholesterol change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • glucose change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • plasma EEQs change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • plasma EDPs change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • LA change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • WEIGHT change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • plasma 20-HETE change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • ABPM change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • OFFICE BLOOD PRESSURE change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • PWA (Augmentation Index; AIx) change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • cfPWV change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • urine DHETs change(baseline compared to post-treatment (ie, after 3 months of treatment))
  • WAIST CIRCUMFERENCE change(baseline compared to post-treatment (ie, after 3 months of treatment))

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristiano Fava

Professor

Universita di Verona

研究点 (2)

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