Effect of a Three Combined Probiotics Supplementation on Weight Loss in Obese/Overweight Children
Condition: Obesity, Childhood
MeSH terms: Overweight; Pediatric Obesity; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder; Placebo
Intervention type(s): Other; Other
Intervention description(s): 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.; Taking 1 pack of placebo powder three times a day before meals for three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Probiotic or placebo group
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; Overweight; Obese; Children; Weight reduction