Fit Child - Clinical Study on Weight Control

NCT03196453 | Withdrawn DMC

• 1 other identifier: T6161/2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Nutrition Disorder, Child; Weight Change, Body

Keywords

overweight; probiotic; weight management

Outcome Measures

Primary Outcomes (1)

• weight gain

  body weight

  3 months

Secondary Outcomes (2)

• Blood biomarkers

  3 months

• Weight change

  3 months

Study Arms (3)

Probiotic

ACTIVE COMPARATOR

Lactobacillus rhamnosus GG

Dietary Supplement: Probiotic

Probiotic and protein

ACTIVE COMPARATOR

Lactobacillus rhamnosus GG and whey protein isolate

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

probiotic and/or placebo intervention in toddlers

Also known as: FITCHI (Fit Child)

Placebo; Probiotic; Probiotic and protein

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

University of Turku and University Hospital Turku

Turku, Varsinaissuomi, 20520, Finland

Location

MeSH Terms

Conditions

Overweight; Child Nutrition Disorders; Body Weight Changes

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Erika Isolauri

  University of Turku, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professori

Model Details: double blind, placebo controlled,

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: May 25, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 5, 2025

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)