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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo powder | Placebo Comparator | Taking 1 pack of placebo powder three times a day before meals for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hung-chih Lin | China Medical University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 40447 | Taiwan |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Probiotic or placebo group
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| Placebo | Other | Taking 1 pack of placebo powder three times a day before meals for three months. |
|
| Up to 3 months. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |