Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth
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
地位
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
注册 (预期的)
阶段
- 不适用
联系人和位置
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
-
-
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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:
- Zbigniew Zbigniew, MD, PhD
- 电话号码:603547517
- 邮箱:zakulaga@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
出版物和有用的链接
一般刊物
- Barczynska R, Kapusniak J, Litwin M, Slizewska K, Szalecki M. Dextrins from Maize Starch as Substances Activating the Growth of Bacteroidetes and Actinobacteria Simultaneously Inhibiting the Growth of Firmicutes, Responsible for the Occurrence of Obesity. Plant Foods Hum Nutr. 2016 Jun;71(2):190-6. doi: 10.1007/s11130-016-0542-9.
- Barczynska R, Bandurska K, Slizewska K, Litwin M, Szalecki M, Libudzisz Z, Kapusniak J. Intestinal Microbiota, Obesity and Prebiotics. Pol J Microbiol. 2015;64(2):93-100.
- Barczynska R, Slizewska K, Litwin M, Szalecki M, Kapusniak J. Effects of dietary fiber preparations made from maize starch on the growth and activity of selected bacteria from the Firmicutes, Bacteroidetes, and Actinobacteria phyla in fecal samples from obese children. Acta Biochim Pol. 2016;63(2):261-6. doi: 10.18388/abp.2015_1068. Epub 2016 Feb 29.
- Litwin M, Sladowska J, Antoniewicz J, Niemirska A, Wierzbicka A, Daszkowska J, Wawer ZT, Janas R, Grenda R. Metabolic abnormalities, insulin resistance, and metabolic syndrome in children with primary hypertension. Am J Hypertens. 2007 Aug;20(8):875-82. doi: 10.1016/j.amjhyper.2007.03.005.
- Litwin M, Michalkiewicz J, Trojanek J, Niemirska A, Wierzbicka A, Szalecki M. Altered genes profile of renin-angiotensin system, immune system, and adipokines receptors in leukocytes of children with primary hypertension. Hypertension. 2013 Feb;61(2):431-6. doi: 10.1161/HYPERTENSIONAHA.111.00181. Epub 2012 Dec 24.
- Pinket AS, Van Lippevelde W, De Bourdeaudhuij I, Deforche B, Cardon G, Androutsos O, Koletzko B, Moreno LA, Socha P, Iotova V, Manios Y, De Craemer M; ToyBox-Study Group. Effect and Process Evaluation of a Cluster Randomized Control Trial on Water Intake and Beverage Consumption in Preschoolers from Six European Countries: The ToyBox-Study. PLoS One. 2016 Apr 11;11(4):e0152928. doi: 10.1371/journal.pone.0152928. eCollection 2016.
- Socha P, Grote V, Gruszfeld D, Janas R, Demmelmair H, Closa-Monasterolo R, Subias JE, Scaglioni S, Verduci E, Dain E, Langhendries JP, Perrin E, Koletzko B; European Childhood Obesity Trial Study Group. Milk protein intake, the metabolic-endocrine response, and growth in infancy: data from a randomized clinical trial. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1776S-1784S. doi: 10.3945/ajcn.110.000596. Epub 2011 Aug 17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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
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