PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition

Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition

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.

Study Overview

• Status: Recruiting
• Conditions: Heathly Volunteers
• Intervention / Treatment: Dietary supplement: PI-YSP-0111 formulation (High-dose); Dietary supplement: PI-YSP-0111 formulation (Low-dose); Dietary supplement: Placebo group(High-dose); Dietary supplement: Placebo group(Low-dose)

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Ta Yang, Professor; Phone Number: 2275 +886-2-27361661; Email: yangrugby@tmu.edu.tw

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 110
      • Recruiting
      • Taipei Medical University
      • Contact: Ming Ta Yang, Professor; Phone Number: 2275 +886-2-27361661; Email: yangrugby@tmu.edu.tw
    • Taipei, Taiwan, Taiwan, 116
      • Recruiting
      • Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
      • Contact: Ming Ta Yang, Professor; Phone Number: 2275 +886-2-27361661; Email: yangrugby@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-dose intervention group	Dietary supplement: PI-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)
Experimental: low-dose intervention group	Dietary supplement: PI-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)
Placebo Comparator: high-dose placebo group	Dietary supplement: Placebo group(High-dose); 6 per day(Maltose powder, Aerosil, Magnesium Stearate)
Placebo Comparator: low-dose placebo group	Dietary supplement: Placebo group(Low-dose); 4 per day(Maltose powder, Aerosil, Magnesium Stearate)

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Yung Shin Pharm. Ind. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: N202603016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No