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

• Sponsor: Children's Memorial Health Institute, Poland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05140070
• Collaborator: Jan Dlugosz University of Czestochowa, Poland (Other), Tymbark MWS Sp. with o.o. Sp. K., Poland (Other), Faculty of Biotechnology and Food Sciences, Lodz University of Technology, Poland (Other), Oncology Center-Institute of Maria Skłodowska - Curie, Poland (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.8
• Patients Per Site Per Month: 5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Child Obesity; Hypertension; NAFLD	Dietary Supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties; Dietary Supplement: Vegetable and fruit mousse; Behavioral: Dietary and physical activity counselling	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomize, double blind, intervention vs controlrandomize, double blind, intervention vs control
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: the same appearance of the mousse (with and without active substance)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 6, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Mousse with prebiotic	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; 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
Active Comparator: Control Mousse without prebiotic	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

Outcome Measures

Primary Outcome Measures

1. BMI z-score change [6 to 9 months]

   Change in age and sex standardized BMI z-scores

Secondary Outcome Measures

1. Bioimpedance [6 to 9 months]

   Change in body composition on bioimpedance (fat-body-mass %)

2. Waist [6 to 9 months]

   Change in waist z-score (cm)

3. Gut microbiota [6 to 9 months]

   change in microbiome composition

4. Triglyceride [6 to 9 months]

   change in triglyceride-parameter of lipid metabolism (mg%)

5. Cholesterol [6 to 9 months]

   change in cholesterol-parameter of lipid metabolism (mg%)

6. Low-density lipoprotein (LDL) [6 to 9 months]

   change in Low-density lipoprotein (LDL)-parameter of lipid metabolism (mg%)

7. high-density lipoprotein (HDL) [6 to 9 months]

   change in high-density lipoprotein (HDL)-parameter of lipid metabolism (mg%)

8. very low-density lipoprotein (VLDL) [6 to 9 months]

   change in very low-density lipoprotein (VLDL)-parameter of lipid metabolism (mg%)

9. apolipoprotein [6 to 9 months]

   change in apolipoprotein-parameter of lipid metabolism (mg%)

10. uric acid [6 to 9 months]

    change in uric acid (mg%)

11. leptin [6 to 9 months]

    change in leptin (ng/mL)

12. adiponectin [6 to 9 months]

    change in adiponectin (ng/mL)

13. glucose, serum [6 to 9 months]

    change in glucose (mg%)

14. insulin, serum [6 to 9 months]

    change in insulin (mcIU/mL)

15. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [6 to 9 months]

    change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), score, normal range<2,5

16. Glutathione (GSH) [6 to 9 months]

    change in Glutathione (GSH) (g Hgb/mcL)

17. glutathione peroxidase (GPx) [6 to 9 months]

    change in glutathione peroxidase (GPx) (mg/dL)

18. total antioxidant status (TAS) [6 to 9 months]

    change in total antioxidant status (TAS) (mcmol/L)

19. tumor necrosis factor α (TNF-alfa) [6 months]

    change in tumor necrosis factor α (TNF-alfa) (ng/mL)

20. interleukin 6 (IL-6) [6 months]

    change in interleukin 6 (IL-6) (ng/mL)

21. Monocyte Chemoattractant Protein-1 (MCP-1) [6 months]

    change in Monocyte Chemoattractant Protein-1 (MCP-1) (ng/mL)

22. Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta [6 months]

    change in Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta (ng/mL)

23. Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES) [6 months]

    change in Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES) (ng/mL)

24. lymphocyte T [6 months]

    change in lymphocyte T (%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Childen's Memorial Health Institute	Warszawa		Poland	03-984

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Piotr Socha, professor, Children's Memorial Health Institute, Poland
• ClinicalTrials.gov Identifier: NCT05140070
• Other Study ID Numbers: PreSTFibre4kids
• First Posted: Dec 1, 2021
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Piotr Socha, professor, Children's Memorial Health Institute, Poland: child; prebiotics; obesity; overweight; treatment
• Additional relevant MeSH terms: Obesity; Pediatric Obesity; Overweight

Study Results

No Results Posted as of Apr 21, 2022