Heathly Volunteers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPI-YSP-0111 formulation (High-dose)
6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
DIETARY_SUPPLEMENTPI-YSP-0111 formulation (Low-dose)
4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
DIETARY_SUPPLEMENTPlacebo group(High-dose)
6 per day(Maltose powder, Aerosil, Magnesium Stearate)
DIETARY_SUPPLEMENTPlacebo group(Low-dose)
4 per day(Maltose powder, Aerosil, Magnesium Stearate)
Sponsors
Taipei Medical University
Yung Shin Pharm. Ind. Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or females aged 18 to 65 years. 2. BMI between 23.0 and 40.0 kg/m². 3. Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females. 4. Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate. 5. Participants have fully understood the study procedures and have signed the informed consent form.
Exclusion criteria
1. Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery. 2. Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (\>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs \[NSAIDs\]). 3. Exposure to unapproved medications, alcohol abuse, or substance abuse. 4. Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded). 5. Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month. 6. Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months. 7. Participation in any other interventional clinical study within the past one month. 8. History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer. 9. Occurrence of major trauma or any surgical procedures within the past one month. 10. History of diabetic ketoacidosis.
Design outcomes
Primary
| Measure | 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 |
| 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 |
Countries
Taiwan
Contacts
CONTACTMing Ta Yang, Professor
Outcome results
None listed