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

20. April 2022 aktualisiert von: Piotr Socha, Children's Memorial Health Institute, Poland

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).

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Piotr Socha, MD, PhD
  • Telefonnummer: +48 501065154
  • E-Mail: p.socha@ipczd.pl

Studieren Sie die Kontaktsicherung

Studienorte

      • Warszawa, Polen, 03-984
        • Rekrutierung
        • The Childen's Memorial Health Institute
        • Kontakt:
          • Piotr Socha, Professor, MD, PhD
          • Telefonnummer: +48 501 065 154
          • E-Mail: zakulaga@gmail.com
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 10 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Aktiver Komparator: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
BMI z-score change
Zeitfenster: 6 to 9 months
Change in age and sex standardized BMI z-scores
6 to 9 months

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Oktober 2021

Primärer Abschluss (Voraussichtlich)

1. Dezember 2022

Studienabschluss (Voraussichtlich)

1. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

23. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. November 2021

Zuerst gepostet (Tatsächlich)

1. Dezember 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PreSTFibre4kids

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).

IPD-Sharing-Zeitrahmen

Immediately following publication. No end date.

IPD-Sharing-Zugriffskriterien

Anyone who wishes to access the data

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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