Overweight and ObesityNCT05140070
Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth
A study testing Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties, Vegetable and fruit mousse and Dietary and physical activity counselling in people with Overweight and Obesity and Child Obesity, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Overweight and Obesity, Child Obesity, Hypertension
- What is being tested?
- Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties, Vegetable and fruit mousse and Dietary and physical activity counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 6 Oct 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- allergy to mousse components
- malabsorption syndrome
- organ failure
- food neophobia
- other diseases or health problems which may interfere with study procedures or safety.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
The Childen's Memorial Health Institute
Warsaw, 03-984
Piotr Socha, Professor, MD, PhD, +48 501 065 154, zakulaga@gmail.com
Zbigniew Zbigniew, MD, PhD, 603547517, zakulaga@gmail.com
About this study
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
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).
Read the 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.
- Conditions
- Overweight and Obesity, Child Obesity, Hypertension, NAFLD
- Being tested
- Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties, Vegetable and fruit mousse, Dietary and physical activity counselling
- Keywords
- child, prebiotics, obesity, overweight, treatment
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity, Hypertension, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic propertiesDietary supplement
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
Vegetable and fruit mousseDietary supplement
All children in the control group will consume on daily basis vegetable and fruit mousse for six months
Dietary and physical activity counsellingBehavioural
All children in the study will obtain 4 dietary and physical activity advice during the course of the study
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mousse with prebiotic Receives: Dietary Supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties; Behavioral: Dietary and physical activity counselling |
| Control | Active comparator | Mousse without prebiotic Receives: Dietary Supplement: Vegetable and fruit mousse; Behavioral: Dietary and physical activity counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score change
Change in age and sex standardized BMI z-scores
Measured: 6 to 9 months
Secondary outcomes (24)
Bioimpedance
Change in body composition on bioimpedance (fat-body-mass %)
Measured: 6 to 9 months
Waist
Change in waist z-score (cm)
Measured: 6 to 9 months
Gut microbiota
change in microbiome composition
Measured: 6 to 9 months
Triglyceride
change in triglyceride-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
Cholesterol
change in cholesterol-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
Low-density lipoprotein (LDL)
change in Low-density lipoprotein (LDL)-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
high-density lipoprotein (HDL)
change in high-density lipoprotein (HDL)-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
very low-density lipoprotein (VLDL)
change in very low-density lipoprotein (VLDL)-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
apolipoprotein
change in apolipoprotein-parameter of lipid metabolism (mg%)
Measured: 6 to 9 months
uric acid
change in uric acid (mg%)
Measured: 6 to 9 months
leptin
change in leptin (ng/mL)
Measured: 6 to 9 months
adiponectin
change in adiponectin (ng/mL)
Measured: 6 to 9 months
glucose, serum
change in glucose (mg%)
Measured: 6 to 9 months
insulin, serum
change in insulin (mcIU/mL)
Measured: 6 to 9 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), score, normal range<2,5
Measured: 6 to 9 months
Glutathione (GSH)
change in Glutathione (GSH) (g Hgb/mcL)
Measured: 6 to 9 months
glutathione peroxidase (GPx)
change in glutathione peroxidase (GPx) (mg/dL)
Measured: 6 to 9 months
total antioxidant status (TAS)
change in total antioxidant status (TAS) (mcmol/L)
Measured: 6 to 9 months
tumor necrosis factor α (TNF-alfa)
change in tumor necrosis factor α (TNF-alfa) (ng/mL)
Measured: 6 months
interleukin 6 (IL-6)
change in interleukin 6 (IL-6) (ng/mL)
Measured: 6 months
Monocyte Chemoattractant Protein-1 (MCP-1)
change in Monocyte Chemoattractant Protein-1 (MCP-1) (ng/mL)
Measured: 6 months
Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta
change in Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta (ng/mL)
Measured: 6 months
Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES)
change in Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES) (ng/mL)
Measured: 6 months
lymphocyte T
change in lymphocyte T (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize, double blind, intervention vs control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Jan Dlugosz University in Czestochowa, 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
- Responsible party
- Principal investigator, Piotr Socha, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140070
- Sponsor's protocol ID
- PreSTFibre4kids
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 27155867Barczynska 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.
PubMed 26373167Barczynska 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.
PubMed 26929930Litwin 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.
PubMed 17679036Litwin 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.
PubMed 23266543Pinket 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.
PubMed 27064274Socha 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.
PubMed 21849603
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05140070
- Acronym / sponsor ID
- PreSTFibre4kids
- Conditions
- Overweight and Obesity, Child Obesity, Hypertension, NAFLD
- Keywords
- child, prebiotics, obesity, overweight, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Collaborators
- Jan Dlugosz University in Czestochowa, 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
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomize, double blind, intervention vs control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties, Behavioral: Dietary and physical activity counsellingMousse with prebiotic |
| Control | Active comparator | Dietary Supplement: Vegetable and fruit mousse, Behavioral: Dietary and physical activity counsellingMousse without prebiotic |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- allergy to mousse components
- malabsorption syndrome
- organ failure
- food neophobia
- other diseases or health problems which may interfere with study procedures or safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic propertiesAll 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 | Intervention |
| Vegetable and fruit mousseAll children in the control group will consume on daily basis vegetable and fruit mousse for six months | Dietary supplement | Control |
| Dietary and physical activity counsellingAll children in the study will obtain 4 dietary and physical activity advice during the course of the study | Behavioural | Control, Intervention |
Primary outcome
BMI z-score change
Time frame: 6 to 9 months
Change in age and sex standardized BMI z-scores
24 secondary outcomes
Bioimpedance
Time frame: 6 to 9 months
Waist
Time frame: 6 to 9 months
Gut microbiota
Time frame: 6 to 9 months
Triglyceride
Time frame: 6 to 9 months
Cholesterol
Time frame: 6 to 9 months
Low-density lipoprotein (LDL)
Time frame: 6 to 9 months
high-density lipoprotein (HDL)
Time frame: 6 to 9 months
very low-density lipoprotein (VLDL)
Time frame: 6 to 9 months
apolipoprotein
Time frame: 6 to 9 months
uric acid
Time frame: 6 to 9 months
leptin
Time frame: 6 to 9 months
adiponectin
Time frame: 6 to 9 months
glucose, serum
Time frame: 6 to 9 months
insulin, serum
Time frame: 6 to 9 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 6 to 9 months
Glutathione (GSH)
Time frame: 6 to 9 months
glutathione peroxidase (GPx)
Time frame: 6 to 9 months
total antioxidant status (TAS)
Time frame: 6 to 9 months
tumor necrosis factor α (TNF-alfa)
Time frame: 6 months
interleukin 6 (IL-6)
Time frame: 6 months
Monocyte Chemoattractant Protein-1 (MCP-1)
Time frame: 6 months
Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta
Time frame: 6 months
Regulated upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES)
Time frame: 6 months
lymphocyte T
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Results publication: PubMed 27155867Barczynska 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.
- Results publication: PubMed 26373167Barczynska 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.
- Results publication: PubMed 26929930Barczynska 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.
- Results publication: PubMed 17679036Litwin 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.
- Results publication: PubMed 23266543Litwin 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.
- Results publication: PubMed 27064274Pinket 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.
- Results publication: PubMed 21849603Socha 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties, Vegetable and fruit mousse and Dietary and physical activity counselling in people with Overweight and Obesity and Child Obesity, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Socha, MD, PhD (+48 501065154, p.socha@ipczd.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score change (time frame: 6 to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140070, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.