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NCT Number: NCT03883191

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

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.

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Key information

Conditions

Obesity, Childhood Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 40447, Taiwan

About this study

The prevalence of obesity in adults was up to 40% in Taiwan. The prevalence of overweight and obesity in Taiwanese boy was over 30%, while close to 30% of Taiwanese girls were overweight and obesity. Obese children are more prone to becoming obese adults and consequently increased risk of many complications, including metabolic syndrome, nonalcoholic fatty liver disease, cardiovascular disease, etc. Therefore, childhood obesity may result in significant public health burden in the future if it was improperly handled. Unfortunately, there is still lack of effective way to reduce weight and long-term weight control except for lifestyle modification.

Recent studies have shown that microflora of the gut are associated with obesity, perhaps one of the cause of obesity. Many studies have shown that the gut microbiota is different between obese individuals and normal-weight individuals. The most significant one is that obese individuals have larger Firmicutes/Bacteroidetes ratio. In the other hand, many studies have confirmed that probiotic was effectively in weight loss in obese adults. However, there are only few research in pediatric population in this issue. Researchers have demonstrated that products containing probiotics are effective in reducing weight, BMI, and serum lipid level in obese child.

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. Every subjects will receive several tests and examinations before and after the study, such as: height, weight, BMI, waist circumference, body fat, blood pressure, blood sugar, blood lipids profile, liver and kidney function, and abdominal ultrasound. Investigators will compare these parameters between these two groups after the study. Investigators expect to follow these subjects for more than one year, to see if this product has persistent effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

  1. Change in the body mass index (BMI) after intervention

    Time frame: Up to 3 months.

    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.

  2. Change in the waist circumference after intervention

    Time frame: Up to 3 months.

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

  3. Change in the body fat after intervention

    Time frame: Up to 3 months.

    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.

  4. Change in the blood pressure after intervention

    Time frame: Up to 3 months.

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

  5. Change in the blood sugar and blood lipids after intervention

    Time frame: Up to 3 months.

    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.

  6. Change in the liver function after intervention

    Time frame: Up to 3 months.

    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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Mar 20, 2019
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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