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Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth

2022年4月20日 更新者:Piotr Socha、Children's Memorial Health Institute, Poland

Development and Implementation of an Innovative Technology for the Production New Generation Fruit and Vegetable Products Enriched With Dietary Fibre Preparation From Potato Starch With Prebiotic Properties for Children and Youth

The main goal of the project is to test fruit and vegetable mousse, with the addition of a fiber preparation made of potato starch with prebiotic properties, on selected clinical, metabolic and immunological parameters in overweight and obese children.

The study will be performed in a group of 80 to 100 children aged 6 to 10 years (pre-pubertal age), using a double-blind procedure. Children will be randomly assigned into two groups, i.e. the intervention group (they will receive a vegetable and fruit mousse with the addition of potato starch fiber preparation with prebiotic properties) and the control group (they will receive an identical preparation in their diet, but without the addition of potato starch fiber preparation).

研究概览

详细说明

Purpose and nature of the study:

The study financed by the National Center for Research and Development is aimed at examining the vegetable and fruit mousse with the addition of a potato starch fiber preparation with prebiotic properties, in terms of preventing overweight and obesity in children and limiting the occurrence of metabolic disorders secondary to obesity.

Description of the procedures Children participating in the study will consume a daily fruit and vegetable mousse with or without the addition (control group) of a fiber-based potato starch preparation with prebiotic properties. Random selection will decide whether child will consume vegetable and fruit mousse with the addition of a fiber-based potato starch preparation with prebiotic properties. The study will be double blinded: neither parent and child, nor the attending physician will know whether the consumed mousse contains a fiber preparation. This method of conducting the study (random selection to the study group and control group and the so-called study blind) aims to eliminate the attitude of both the study participant and the observer to the therapy, which could affect the final assessment.

Children will take the mousse every day for six months (6 months). In order to evaluate the effect of fruit and vegetable mousse with the addition of a fiber preparation made of potato starch with prebiotic properties, the following tests will be performed: measurements of height, weight and, based on this measurements body mass index (BMI) will be calculated, waist circumference and blood pressure, bioimpedance test to assess the content of adipose and muscle tissue in the body, ultrasound of the carotid vessels and the liver, the speed of the pulse wave using the oscillometric method, the elastographic examination with a fibroscan, the examination of the composition of the intestinal flora in a stool sample, and a venous blood sample (7-10 ml volume) will be taken to evaluate lipid, carbohydrate metabolism, liver function, adipose tissue function, antioxidant status, and immune response parameters. The mentioned tests will be performed three times during the observation, i.e. at the time of enrollment in the study, after 6 months of taking the fruit and vegetable mousse and 3 months after the end of the vegetable and fruit mousse. In connection with participation in the study, the Child and Parents will be provided with dietary and physical activity advice as well as psychologist's advice on the day of enrollment in the study and at 3-month intervals up to 9 months from the start of participation in the study. Additionally, 3 months after starting taking the fruit and vegetable mousse, anthropometric and blood pressure measurements will be performed. During the participation in the study possible side effects will be registered.

A questionnaire containing questions about the child's date of birth, questions about the child's general health and taking medications, about the socio-demographic situation of the family, and food frequency questions will be completed.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Piotr Socha, MD, PhD
  • 电话号码:+48 501065154
  • 邮箱p.socha@ipczd.pl

研究联系人备份

  • 姓名:Zbigniew Kułaga, MD, PhD
  • 电话号码:+48 603547517
  • 邮箱zakulaga@gmail.com

学习地点

      • Warszawa、波兰、03-984
        • 招聘中
        • The Childen's Memorial Health Institute
        • 接触:
          • Piotr Socha, Professor, MD, PhD
          • 电话号码:+48 501 065 154
          • 邮箱zakulaga@gmail.com
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 10年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • overweight or obesity according to World Health Organization (WHO) definition
  • in 20 patients additionally to overweight or obesity also increase blood pressure
  • in 20 patients additionally to overweight or obesity also liver steatosis
  • willingness to participate

Exclusion Criteria:

  • allergy to mousse components
  • malabsorption syndrome
  • organ failure
  • food neophobia
  • other diseases or health problems which may interfere with study procedures or safety.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
Mousse with prebiotic
All children in the intervention group will consume on daily basis vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties for six months
All children in the study will obtain 4 dietary and physical activity advice during the course of the study
有源比较器:Control
Mousse without prebiotic
All children in the study will obtain 4 dietary and physical activity advice during the course of the study
All children in the control group will consume on daily basis vegetable and fruit mousse for six months

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
BMI z-score change
大体时间:6 to 9 months
Change in age and sex standardized BMI z-scores
6 to 9 months

次要结果测量

结果测量
措施说明
大体时间
Bioimpedance
大体时间:6 to 9 months
Change in body composition on bioimpedance (fat-body-mass %)
6 to 9 months
Waist
大体时间:6 to 9 months
Change in waist z-score (cm)
6 to 9 months
Gut microbiota
大体时间:6 to 9 months
change in microbiome composition
6 to 9 months
Triglyceride
大体时间:6 to 9 months
change in triglyceride-parameter of lipid metabolism (mg%)
6 to 9 months
Cholesterol
大体时间:6 to 9 months
change in cholesterol-parameter of lipid metabolism (mg%)
6 to 9 months
Low-density lipoprotein (LDL)
大体时间:6 to 9 months
change in Low-density lipoprotein (LDL)-parameter of lipid metabolism (mg%)
6 to 9 months
high-density lipoprotein (HDL)
大体时间:6 to 9 months
change in high-density lipoprotein (HDL)-parameter of lipid metabolism (mg%)
6 to 9 months
very low-density lipoprotein (VLDL)
大体时间:6 to 9 months
change in very low-density lipoprotein (VLDL)-parameter of lipid metabolism (mg%)
6 to 9 months
apolipoprotein
大体时间:6 to 9 months
change in apolipoprotein-parameter of lipid metabolism (mg%)
6 to 9 months
uric acid
大体时间:6 to 9 months
change in uric acid (mg%)
6 to 9 months
leptin
大体时间:6 to 9 months
change in leptin (ng/mL)
6 to 9 months
adiponectin
大体时间:6 to 9 months
change in adiponectin (ng/mL)
6 to 9 months
glucose, serum
大体时间:6 to 9 months
change in glucose (mg%)
6 to 9 months
insulin, serum
大体时间:6 to 9 months
change in insulin (mcIU/mL)
6 to 9 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
大体时间:6 to 9 months
change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), score, normal range<2,5
6 to 9 months
Glutathione (GSH)
大体时间:6 to 9 months
change in Glutathione (GSH) (g Hgb/mcL)
6 to 9 months
glutathione peroxidase (GPx)
大体时间:6 to 9 months
change in glutathione peroxidase (GPx) (mg/dL)
6 to 9 months
total antioxidant status (TAS)
大体时间:6 to 9 months
change in total antioxidant status (TAS) (mcmol/L)
6 to 9 months
tumor necrosis factor α (TNF-alfa)
大体时间:6 months
change in tumor necrosis factor α (TNF-alfa) (ng/mL)
6 months
interleukin 6 (IL-6)
大体时间:6 months
change in interleukin 6 (IL-6) (ng/mL)
6 months
Monocyte Chemoattractant Protein-1 (MCP-1)
大体时间:6 months
change in Monocyte Chemoattractant Protein-1 (MCP-1) (ng/mL)
6 months
Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta
大体时间:6 months
change in Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta (ng/mL)
6 months
Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES)
大体时间:6 months
change in Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES) (ng/mL)
6 months
lymphocyte T
大体时间:6 months
change in lymphocyte T (%)
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月6日

初级完成 (预期的)

2022年12月1日

研究完成 (预期的)

2023年6月1日

研究注册日期

首次提交

2021年8月23日

首先提交符合 QC 标准的

2021年11月17日

首次发布 (实际的)

2021年12月1日

研究记录更新

最后更新发布 (实际的)

2022年4月21日

上次提交的符合 QC 标准的更新

2022年4月20日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • PreSTFibre4kids

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).

IPD 共享时间框架

Immediately following publication. No end date.

IPD 共享访问标准

Anyone who wishes to access the data

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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