Nutrition Disorder, Child, Overweight, Weight Change, Body
Conditions
Keywords
overweight, probiotic, weight management
Brief summary
Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted
Detailed description
In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG. The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers. Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.
Interventions
DIETARY_SUPPLEMENTProbiotic
probiotic and/or placebo intervention in toddlers
Sponsors
University of Turku
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
double blind, placebo controlled,
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development \-
Exclusion criteria
Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight gain | 3 months | body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarkers | 3 months | Subar |
| Weight change | 3 months | Weight change |
Countries
Finland
Outcome results
None listed