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).

Study Overview

• Status: Recruiting
• Conditions: Hypertension; NAFLD; Overweight and Obesity; Child Obesity
• Intervention / Treatment: Dietary supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties; Behavioral: Dietary and physical activity counselling; Dietary supplement: Vegetable and fruit mousse

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piotr Socha, MD, PhD; Phone Number: +48 501065154; Email: p.socha@ipczd.pl
• Study Contact Backup: Name: Zbigniew Kułaga, MD, PhD; Phone Number: +48 603547517; Email: zakulaga@gmail.com

Study Locations

• Poland
  • Warszawa, Poland, 03-984
    • Recruiting
    • The Childen's Memorial Health Institute
    • Contact: Piotr Socha, Professor, MD, PhD; Phone Number: +48 501 065 154; Email: zakulaga@gmail.com
    • Contact: Zbigniew Zbigniew, MD, PhD; Phone Number: 603547517; Email: zakulaga@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Mousse with prebiotic	Dietary supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties; 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; Behavioral: Dietary and physical activity counselling; All children in the study will obtain 4 dietary and physical activity advice during the course of the study
Active Comparator: Control; Mousse without prebiotic	Behavioral: Dietary and physical activity counselling; All children in the study will obtain 4 dietary and physical activity advice during the course of the study; Dietary supplement: Vegetable and fruit mousse; All children in the control group will consume on daily basis vegetable and fruit mousse for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI z-score change	Change in age and sex standardized BMI z-scores	6 to 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Memorial Health Institute, Poland
• Collaborators: Jan Dlugosz University in Czestochowa; Tymbark MWS Sp. with o.o. Sp. K., Poland; Faculty of Biotechnology and Food Sciences, Lodz University of Technology, Poland; Oncology Center-Institute of Maria Skłodowska - Curie, Poland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: treatment; obesity; overweight; child; prebiotics
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: PreSTFibre4kids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No