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

NCT05140070 | Unknown

• 1 other identifier: PreSTFibre4kids
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity; Child Obesity; Hypertension; NAFLD

Keywords

child; prebiotics; obesity; overweight; treatment

Outcome Measures

Primary Outcomes (1)

• BMI z-score change

  Change in age and sex standardized BMI z-scores

  6 to 9 months

Secondary Outcomes (24)

• Bioimpedance

  6 to 9 months

• Waist

  6 to 9 months

• Gut microbiota

  6 to 9 months

• Triglyceride

  6 to 9 months

• Cholesterol

  6 to 9 months

Study Arms (2)

Intervention

EXPERIMENTAL

Mousse with prebiotic

Dietary Supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties; Behavioral: Dietary and physical activity counselling

Control

ACTIVE COMPARATOR

Mousse without prebiotic

Dietary Supplement: Vegetable and fruit mousse; Behavioral: Dietary and physical activity counselling

Interventions

Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties DIETARY_SUPPLEMENT

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

Intervention

Vegetable and fruit mousse DIETARY_SUPPLEMENT

All children in the control group will consume on daily basis vegetable and fruit mousse for six months

Control

Dietary and physical activity counselling BEHAVIORAL

All children in the study will obtain 4 dietary and physical activity advice during the course of the study

Control; Intervention

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The Childen's Memorial Health Institute

Warsaw, 03-984, Poland

RECRUITING

Related Publications (7)

• 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.

  PMID: 27155867 RESULT

• 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.

  PMID: 26373167 RESULT

• 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.

  PMID: 26929930 RESULT

• 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.

  PMID: 17679036 RESULT

• 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.

  PMID: 23266543 RESULT

• 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.

  PMID: 27064274 RESULT

• 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.

  PMID: 21849603 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Pediatric Obesity; Hypertension; Non-alcoholic Fatty Liver Disease

Interventions

Vegetables; Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena

Central Study Contacts

Piotr Socha, MD, PhD

CONTACT

+48 501065154; p.socha@ipczd.pl

Zbigniew Kułaga, MD, PhD

CONTACT

+48 603547517; zakulaga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the same appearance of the mousse (with and without active substance)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: randomize, double blind, intervention vs control

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: December 1, 2021
• Study Start: October 6, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

PL (1)