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| Name | Class |
|---|---|
| Yung Shin Pharm. Ind. Co., Ltd. | INDUSTRY |
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The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.
All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-dose intervention group | Experimental |
| |
| low-dose intervention group | Experimental |
| |
| high-dose placebo group | Placebo Comparator |
| |
| low-dose placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PI-YSP-0111 formulation (High-dose) | Dietary Supplement | 6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ketone Bodies | week0 and week8 | |
| Albumin | Week0 and week8 | |
| Aspartate Aminotransferase (AST) | week0 and week8 | |
| Alanine Aminotransferase (ALT) | week0 and week8 | |
| Gamma-Glutamyl Transferase (GGT) | week0 and week8 | |
| Blood Creatinine | week0 and week8 | |
| Blood Urea Nitrogen (BUN) | week0 and week8 | |
| Uric Acid | week0 and week8 | |
| Sodium (Na⁺) | week0 and week8 | |
| Potassium (K⁺) | week0 and week8 | |
| Free Fatty Acids (FFA) | week0 and week8 | |
| Thyroid Stimulating Hormone (TSH) | week0 and week8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Ta Yang, Professor | Contact | +886-2-27361661 | 2275 | yangrugby@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Recruiting | Taipei | Taiwan | 110 | Taiwan |
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Participants will be randomly assigned to one of four groups: a high-dose intervention group, a low-dose intervention group, a high-dose placebo group, and a low-dose placebo group (35 participants per group).
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| PI-YSP-0111 formulation (Low-dose) | Dietary Supplement | 4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate) |
|
| Placebo group(High-dose) | Dietary Supplement | 6 per day(Maltose powder, Aerosil, Magnesium Stearate) |
|
| Placebo group(Low-dose) | Dietary Supplement | 4 per day(Maltose powder, Aerosil, Magnesium Stearate) |
|
| white blood cell (WBC) count/automated differential | week0 and week8 |
| red blood cell (RBC) count | week0 and week8 |
| hemoglobin | week0 and week8 |
| hematocrit | week0 and week8 |
| platelet count | week0 and week8 |
| mean corpuscular volume (M.C.V) | week0 and week8 |
| mean corpuscular hemoglobin concentration (M.C.H.C) | week0 and week8 |
| total cholesterol (TC) | week0 and week8 |
| high-density lipoprotein cholesterol (HDL-C)non-HDL-C | week0 and week8 |
| low-density lipoprotein cholesterol (LDL-C) | week0 and week8 |
| triglycerides (TG) | week0 and week8 |
| glucose AC | week0 and week8 |
| Height | week0 , week4 and week8 |
| Weight | week0 , week4 and week8 |
| Body Mass Index (BMI) | week0 , week4 and week8 |
| Body Composition (muscle mass, fat mass, visceral fat level) | week0 , week4 and week8 |
| Hip Circumference | week0 , week4 and week8 |
| Waist-to-Hip Ratio (WHR) | week0 , week4 and week8 |
| Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction)) | week0, week8 |
| Next-Generation Sequencing (NGS) | week0 and week8 |
| Urinalysis | week0 and week8 |
| Dietary Record | week0 , week4 and week8 |
| Bowel Movement Record | week0 , week4 and week8 |
| Gastrointestinal Questionnaire | Week0 , week4 and week8 |
| Taipei Municipal WanFang Hospital(Managed by Taipei Medical University) | Recruiting | Taipei | Taiwan | 116 | Taiwan |
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