Fit Child - Clinical Study on Weight Control

Not Applicable

• Conditions: Overweight; Weight Change, Body; Nutrition Disorder, Child
• Interventions: Dietary Supplement: Probiotic

• 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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23
• Study Start: 2017-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic and protein	Probiotic	Lactobacillus rhamnosus GG and whey protein isolate
Placebo	Probiotic	Placebo
Probiotic	Probiotic	Lactobacillus rhamnosus GG

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