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

20. april 2022 oppdatert av: 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).

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 10 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Aktiv 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
BMI z-score change
Tidsramme: 6 to 9 months
Change in age and sex standardized BMI z-scores
6 to 9 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. oktober 2021

Primær fullføring (Forventet)

1. desember 2022

Studiet fullført (Forventet)

1. juni 2023

Datoer for studieregistrering

Først innsendt

23. august 2021

Først innsendt som oppfylte QC-kriteriene

17. november 2021

Først lagt ut (Faktiske)

1. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PreSTFibre4kids

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Immediately following publication. No end date.

Tilgangskriterier for IPD-deling

Anyone who wishes to access the data

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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