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

NCT07618000 | Recruiting

• 1 other identifier: N202603016
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Heathly Volunteers

Outcome Measures

Primary Outcomes (36)

• 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

Study Arms (4)

high-dose intervention group

EXPERIMENTAL

Dietary Supplement: PI-YSP-0111 formulation (High-dose)

low-dose intervention group

EXPERIMENTAL

Dietary Supplement: PI-YSP-0111 formulation (Low-dose)

high-dose placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo group(High-dose)

low-dose placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo group(Low-dose)

Interventions

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)

high-dose intervention group

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)

low-dose intervention group

Placebo group(High-dose) DIETARY_SUPPLEMENT

6 per day(Maltose powder, Aerosil, Magnesium Stearate)

high-dose placebo group

Placebo group(Low-dose) DIETARY_SUPPLEMENT

4 per day(Maltose powder, Aerosil, Magnesium Stearate)

low-dose placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females aged 18 to 65 years.
• BMI between 23.0 and 40.0 kg/m².
• Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
• 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.
• Participants have fully understood the study procedures and have signed the informed consent form.

You may not qualify if:

• Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
• 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 \[NSAIDs\]).
• Exposure to unapproved medications, alcohol abuse, or substance abuse.
• 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).
• Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
• Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.
• Participation in any other interventional clinical study within the past one month.
• History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.
• Occurrence of major trauma or any surgical procedures within the past one month.
• History of diabetic ketoacidosis.

Sponsors & Collaborators

• Taipei Medical University: lead
• Yung Shin Pharm. Ind. Co., Ltd.: collaborator

Study Sites (2)

Taipei Medical University

Taipei, Taiwan, 110, Taiwan

RECRUITING

Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)

Taipei, Taiwan, 116, Taiwan

RECRUITING

Central Study Contacts

Ming Ta Yang, Professor

CONTACT

+886-2-27361661; yangrugby@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-04

Locations

TW (2)