An interventional study of Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties and Vegetable and fruit mousse in Overweight and Obesity, Child Obesity and Hypertension, sponsored by Children's Memorial Health Institute, Poland. Status unknown at 1 site in Poland. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Mousse with prebiotic
Dietary Supplement: Vegetable and fruit mousse enriched with a fiber preparation from potato starch with prebiotic properties · Behavioral: Dietary and physical activity counselling
Mousse without prebiotic
Dietary Supplement: Vegetable and fruit mousse · Behavioral: Dietary and physical activity counselling
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 control group will consume on daily basis vegetable and fruit mousse for six months
All children in the study will obtain 4 dietary and physical activity advice during the course of the study
BMI z-score change
Change in age and sex standardized BMI z-scores
Time frame: 6 to 9 months
Bioimpedance
Change in body composition on bioimpedance (fat-body-mass %)
Time frame: 6 to 9 months
Waist
Change in waist z-score (cm)
Time frame: 6 to 9 months
Gut microbiota
change in microbiome composition
Time frame: 6 to 9 months
Triglyceride
change in triglyceride-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
Cholesterol
change in cholesterol-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
Low-density lipoprotein (LDL)
change in Low-density lipoprotein (LDL)-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
high-density lipoprotein (HDL)
change in high-density lipoprotein (HDL)-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
very low-density lipoprotein (VLDL)
change in very low-density lipoprotein (VLDL)-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
apolipoprotein
change in apolipoprotein-parameter of lipid metabolism (mg%)
Time frame: 6 to 9 months
uric acid
change in uric acid (mg%)
Time frame: 6 to 9 months
leptin
change in leptin (ng/mL)
Time frame: 6 to 9 months
adiponectin
change in adiponectin (ng/mL)
Time frame: 6 to 9 months
glucose, serum
change in glucose (mg%)
Time frame: 6 to 9 months
insulin, serum
change in insulin (mcIU/mL)
Time frame: 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
Time frame: 6 to 9 months
Glutathione (GSH)
change in Glutathione (GSH) (g Hgb/mcL)
Time frame: 6 to 9 months
glutathione peroxidase (GPx)
change in glutathione peroxidase (GPx) (mg/dL)
Time frame: 6 to 9 months
total antioxidant status (TAS)
change in total antioxidant status (TAS) (mcmol/L)
Time frame: 6 to 9 months
tumor necrosis factor α (TNF-alfa)
change in tumor necrosis factor α (TNF-alfa) (ng/mL)
Time frame: 6 months
interleukin 6 (IL-6)
change in interleukin 6 (IL-6) (ng/mL)
Time frame: 6 months
Monocyte Chemoattractant Protein-1 (MCP-1)
change in Monocyte Chemoattractant Protein-1 (MCP-1) (ng/mL)
Time frame: 6 months
Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta
change in Macrophage Inflammatory Protein-1 (MIP-1) alfa and beta (ng/mL)
Time frame: 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)
Time frame: 6 months
lymphocyte T
change in lymphocyte T (%)
Time frame: 6 months
Plan to share: Yes — Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf, Csr
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Children's Memorial Health Institute, Poland