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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140070
• Other study ID #: PreSTFibre4kids
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Children's Memorial Health Institute, Poland
• Contact: Piotr Socha, MD, PhD
• Phone: +48 501065154
• Email: p.socha[@]ipczd.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Obesity
• Hypertension
• NAFLD
• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity

Intervention

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
• Vegetable and fruit mousse
All children in the control group will consume on daily basis vegetable and fruit mousse 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

Locations

Country	Name	City	State
Poland	The Childen's Memorial Health Institute	Warszawa

Sponsors (5)

Lead Sponsor	Collaborator
Children's Memorial Health Institute, Poland	Faculty of Biotechnology and Food Sciences, Lodz University of Technology, Poland, Jan Dlugosz University of Czestochowa, Poland, Oncology Center-Institute of Maria Sklodowska - Curie, Poland, Tymbark MWS Sp. with o.o. Sp. K., Poland

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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 o — View Citation

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- — View Citation

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. — View Citation

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 — View Citation

Socha P, Grote V, Gruszfeld D, Janas R, Demmelmair H, Closa-Monasterolo R, Subías 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 respons — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score change	Change in age and sex standardized BMI z-scores	6 to 9 months
Secondary	Bioimpedance	Change in body composition on bioimpedance (fat-body-mass %)	6 to 9 months
Secondary	Waist	Change in waist z-score (cm)	6 to 9 months
Secondary	Gut microbiota	change in microbiome composition	6 to 9 months
Secondary	Triglyceride	change in triglyceride-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	Cholesterol	change in cholesterol-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	Low-density lipoprotein (LDL)	change in Low-density lipoprotein (LDL)-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	high-density lipoprotein (HDL)	change in high-density lipoprotein (HDL)-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	very low-density lipoprotein (VLDL)	change in very low-density lipoprotein (VLDL)-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	apolipoprotein	change in apolipoprotein-parameter of lipid metabolism (mg%)	6 to 9 months
Secondary	uric acid	change in uric acid (mg%)	6 to 9 months
Secondary	leptin	change in leptin (ng/mL)	6 to 9 months
Secondary	adiponectin	change in adiponectin (ng/mL)	6 to 9 months
Secondary	glucose, serum	change in glucose (mg%)	6 to 9 months
Secondary	insulin, serum	change in insulin (mcIU/mL)	6 to 9 months
Secondary	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
Secondary	Glutathione (GSH)	change in Glutathione (GSH) (g Hgb/mcL)	6 to 9 months
Secondary	glutathione peroxidase (GPx)	change in glutathione peroxidase (GPx) (mg/dL)	6 to 9 months
Secondary	total antioxidant status (TAS)	change in total antioxidant status (TAS) (mcmol/L)	6 to 9 months
Secondary	tumor necrosis factor a (TNF-alfa)	change in tumor necrosis factor a (TNF-alfa) (ng/mL)	6 months
Secondary	interleukin 6 (IL-6)	change in interleukin 6 (IL-6) (ng/mL)	6 months
Secondary	Monocyte Chemoattractant Protein-1 (MCP-1)	change in Monocyte Chemoattractant Protein-1 (MCP-1) (ng/mL)	6 months
Secondary	Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta	change in Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta (ng/mL)	6 months
Secondary	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
Secondary	lymphocyte T	change in lymphocyte T (%)	6 months