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| Name | Class |
|---|---|
| TCI Co., Ltd. | INDUSTRY |
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To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.
The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.
A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Take one packet (6 grams) of powder orally once daily. The probiotics contain fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, silicon dioxide, and Lactobacillus delbrueckii subsp. Bulgaricus. |
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| Placebo | Placebo Comparator | Placebo contains fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, and silicon dioxide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Probiotics contains a probiotic known as Lactobacillus delbrueckii subsp. Bulgaricus, a key bacterium utilized in the production of yogurt, cheeses, and various naturally fermented products. Studies suggest that the metabolites of Lactobacillus bulgaricus can enhance immunity and digestion, reduce the risk of infection, and lower blood cholesterol levels. The composition of probiotics has been developed by TCI CO., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Comparing the changes between Day 0 and Day 84 | 84 days |
| Body fat | Comparing the changes between Day 0 and Day 84 | 84 days |
| BMI | Comparing the changes between Day 0 and Day 84 | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| ALT and AST (U/L) in Blood composition | Comparing the changes in ALT and AST (alanine aminotransferase, aspartate aminotransferase) in the blood between Day 0 and Day 84 | 84 days |
| CRE, BUN and GLU-AC (mg/dL) in Blood composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuo-Chin Huang, PhD | China Medical University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 404327 | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 | Feb 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Participants were randomly assigned to either the placebo or probiotics group, receiving continuous administration for 12 weeks. Measurements of weight, BMI, and body fat were taken on days 0, 28, 56, and 84 of the treatment period. Additionally, 15 mL of fasting blood was drawn on both the first and 84th day.
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| Placebo | Dietary Supplement | Placebo is provided by TCI CO., Ltd. |
|
Comparing the changes in CRE, BUN, and GLU-AC (creatinine, blood urea nitrogen, fasting blood glucose) in the blood between Day 0 and Day 84
| 84 days |
| Changes in glycated hemoglobin | Comparing the changes in hemoglobin A1c between Day 0 and Day 84. | 84 days |
| Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition | Comparing the changes in CHOL, TG, HDL, and LDL-C (cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) between Day 0 and Day 84. | 84 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D019602 |
| Food and Beverages |