Fit Child - Clinical Study on Weight Control
- Conditions
- OverweightWeight Change, BodyNutrition Disorder, Child
- Registration Number
- NCT03196453
- Lead Sponsor
- Turku University Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 45
2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development
-
Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method weight gain 3 months body weight
- Secondary Outcome Measures
Name Time Method Weight change 3 months Weight change
Blood biomarkers 3 months Subar
Trial Locations
- Locations (1)
University of Turku and University Hospital Turku
🇫🇮Turku, Varsinaissuomi, Finland
University of Turku and University Hospital Turku🇫🇮Turku, Varsinaissuomi, FinlandErika Isolauri, MD, PhDContact+35823130000eriiso@utu.fi