Clinical trial NCT05140070: Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Child Obesity
Hypertension
NAFLD
Keywords: child
prebiotics
obesity
overweight
treatment
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Jan Dlugosz University in Czestochowa
name: Tymbark MWS Sp. with o.o. Sp. K., Poland
name: Faculty of Biotechnology and Food Sciences, Lodz University of Technology, Poland
name: Oncology Center-Institute of Maria Skłodowska - Curie, Poland
First posted: 2021-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize, double blind, intervention vs control
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI z-score change
timeFrame: 6 to 9 months
Secondary outcomes:
measure: Bioimpedance
timeFrame: 6 to 9 months
measure: Waist
timeFrame: 6 to 9 months
measure: Gut microbiota
timeFrame: 6 to 9 months
measure: Triglyceride
timeFrame: 6 to 9 months
measure: Cholesterol
timeFrame: 6 to 9 months
measure: Low-density lipoprotein (LDL)
timeFrame: 6 to 9 months
measure: high-density lipoprotein (HDL)
timeFrame: 6 to 9 months
measure: very low-density lipoprotein (VLDL)
timeFrame: 6 to 9 months
measure: apolipoprotein
timeFrame: 6 to 9 months
measure: uric acid
timeFrame: 6 to 9 months
measure: leptin
timeFrame: 6 to 9 months
measure: adiponectin
timeFrame: 6 to 9 months
measure: glucose, serum
timeFrame: 6 to 9 months
measure: insulin, serum
timeFrame: 6 to 9 months
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 6 to 9 months
measure: Glutathione (GSH)
timeFrame: 6 to 9 months
measure: glutathione peroxidase (GPx)
timeFrame: 6 to 9 months
measure: total antioxidant status (TAS)
timeFrame: 6 to 9 months
measure: tumor necrosis factor α (TNF-alfa)
timeFrame: 6 months
measure: interleukin 6 (IL-6)
timeFrame: 6 months
measure: Monocyte Chemoattractant Protein-1 (MCP-1)
timeFrame: 6 months
measure: Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta
timeFrame: 6 months
measure: Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES)
timeFrame: 6 months
measure: lymphocyte T
timeFrame: 6 months
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: The Childen's Memorial Health Institute
Study officials:
References:
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. Plant Foods Hum Nutr. 2016 Jun;71(2):190-6. doi: 10.1007/s11130-016-0542-9.
citation: 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.
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 obese children. Acta Biochim Pol. 2016;63(2):261-6. doi: 10.18388/abp.2015_1068. Epub 2016 Feb 29.
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. doi: 10.1016/j.amjhyper.2007.03.005.
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):431-6. doi: 10.1161/HYPERTENSIONAHA.111.00181. Epub 2012 Dec 24.
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 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.
citation: 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.