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Fit Child - Clinical Study on Weight Control (FITCHI)

Primary Purpose

Overweight, Nutrition Disorder, Child, Weight Change, Body

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, probiotic, weight management

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Turku and University Hospital Turku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Probiotic and protein

Placebo

Arm Description

Lactobacillus rhamnosus GG

Lactobacillus rhamnosus GG and whey protein isolate

Placebo

Outcomes

Primary Outcome Measures

weight gain
body weight

Secondary Outcome Measures

Blood biomarkers
Subar
Weight change
Weight change

Full Information

First Posted
June 20, 2017
Last Updated
June 22, 2017
Sponsor
Turku University Hospital
Collaborators
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT03196453
Brief Title
Fit Child - Clinical Study on Weight Control
Acronym
FITCHI
Official Title
Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Nutrition Disorder, Child, Weight Change, Body
Keywords
overweight, probiotic, weight management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind, placebo controlled,
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus GG
Arm Title
Probiotic and protein
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus GG and whey protein isolate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
FITCHI (Fit Child)
Intervention Description
probiotic and/or placebo intervention in toddlers
Primary Outcome Measure Information:
Title
weight gain
Description
body weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood biomarkers
Description
Subar
Time Frame
3 months
Title
Weight change
Description
Weight change
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seppo Salminen, PhD
Phone
+35823336880
Email
sepsal@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Isolauri, MD, PhD
Phone
+3582313000
Email
eriiso@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Isolauri
Organizational Affiliation
University of Turku, Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku and University Hospital Turku
City
Turku
State/Province
Varsinaissuomi
ZIP/Postal Code
20520
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Isolauri, MD, PhD
Phone
+35823130000
Email
eriiso@utu.fi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared once the study has been completed and analysed

Learn more about this trial

Fit Child - Clinical Study on Weight Control

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