NCT03883191

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Obesity, Childhood

Interventions

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

Timeline

• Start date: 2017-10-24
• Primary completion: 2018-02-24
• Completion: 2022-04-18
• First posted: 2019-03-20
• Last updated: 2022-10-21

Locations

1 site across 1 country: Taiwan