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

NCT05140070 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-21

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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

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

DIETARY_SUPPLEMENT

Vegetable and fruit mousse

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

BEHAVIORAL

Dietary and physical activity counselling

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

Sponsors & Collaborators

  • Jan Dlugosz University in Czestochowa

    collaborator OTHER

  • Tymbark MWS Sp. with o.o. Sp. K., Poland

    collaborator UNKNOWN

  • Faculty of Biotechnology and Food Sciences, Lodz University of Technology, Poland

    collaborator UNKNOWN

  • Oncology Center-Institute of Maria Skłodowska - Curie, Poland

    collaborator UNKNOWN

  • Children's Memorial Health Institute, Poland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140070 on ClinicalTrials.gov