Effect of a Three Combined Probiotics Supplementation on Weight Loss in Obese/Overweight Children

NCT03883191 | Completed

• 1 other identifier: CMUH105-REC2-096
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This program is a double-blind, randomized, placebo-controlled study. Investigators expect to enroll 100 overweight or obese children those ages 6 to 18 years. A product that containing three probiotics will be prescribed for study group for 12 weeks plus diet and exercise guidance, while the control group will be given a placebo plus diet and exercise guidance.

Conditions

Obesity, Childhood

Keywords

Probiotics; Overweight; Obese; Children; Weight reduction

Outcome Measures

Primary Outcomes (6)

• Change in the body mass index (BMI) after intervention

  Body weight (kg) and height (m) will be combined to report BMI in kg/m\^2, normal BMI value is defined by the "Children's and Adolescent Growth Body Mass Index Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013. Probiotics and placebo group BMI value will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

• Change in the waist circumference after intervention

  Waist circumference in centimeters, probiotics and placebo group waist circumference value will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

• Change in the body fat after intervention

  Body fat (%) in percentage of body weight, probiotics and placebo group body fat percentage will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

• Change in the blood pressure after intervention

  Blood pressure in mmHg, probiotics and placebo group blood pressure value will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

• Change in the blood sugar and blood lipids after intervention

  Blood sugar and blood lipids in mg/dl, probiotics and placebo group blood sugar and blood lipids value will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

• Change in the liver function after intervention

  Liver function is defined as glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT) in IU/L, probiotics and placebo group GOT and GPT value will be presented as an average, lower values represent a better outcome.

  Up to 3 months.

Study Arms (2)

Mix probiotics powder

EXPERIMENTAL

Taking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months.

Other: L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder

Placebo powder

PLACEBO COMPARATOR

Taking 1 pack of placebo powder three times a day before meals for three months.

Other: Placebo

Interventions

L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder OTHER

Taking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months.

Mix probiotics powder

Placebo OTHER

Taking 1 pack of placebo powder three times a day before meals for three months.

Placebo powder

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Over 6 years old under 18 years old.
• Overweight or obese children without potential disease.Overweight or obese children is defined by the "Children's and Adolescent Growth Body Mass Index (BMI) Recommended Values" published by the National Health Agency of the Ministry of Health and Welfare on June 11, 2013.

You may not qualify if:

• There are major potential diseases, such as congenital heart disease, severe asthma, chronic hepatitis, renal dysfunction, neurodegenerative diseases and major genetic diseases.
• Drugs such as weight loss drugs, hypolipidemic drugs, hypoglycemic agents, blood pressure lowering drugs, oral steroids, and hormone supplements are being used.
• Those who use probiotics or related products for a long time.
• Those who use antibiotics during the test.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Hung-chih Lin

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Probiotic or placebo group

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 20, 2019
• Study Start: October 24, 2017
• Primary Completion: February 24, 2018
• Study Completion: April 18, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

TW (1)