- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05140070
Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth
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
Status
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
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Piotr Socha, MD, PhD
- Telefonnummer: +48 501065154
- E-post: p.socha@ipczd.pl
Studer Kontakt Backup
- Navn: Zbigniew Kułaga, MD, PhD
- Telefonnummer: +48 603547517
- E-post: zakulaga@gmail.com
Studiesteder
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Warszawa, Polen, 03-984
- Rekruttering
- The Childen's Memorial Health Institute
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Ta kontakt med:
- Piotr Socha, Professor, MD, PhD
- Telefonnummer: +48 501 065 154
- E-post: zakulaga@gmail.com
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Ta kontakt med:
- Zbigniew Zbigniew, MD, PhD
- Telefonnummer: 603547517
- E-post: zakulaga@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PreSTFibre4kids
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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