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NCT Number: NCT07618000

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.

Recruiting

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Key information

Conditions

Heathly Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

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)

Primary outcomes

  1. Serum Ketone Bodies

    Time frame: week0 and week8

  2. Albumin

    Time frame: Week0 and week8

  3. Aspartate Aminotransferase (AST)

    Time frame: week0 and week8

  4. Alanine Aminotransferase (ALT)

    Time frame: week0 and week8

  5. Gamma-Glutamyl Transferase (GGT)

    Time frame: week0 and week8

  6. Blood Creatinine

    Time frame: week0 and week8

  7. Blood Urea Nitrogen (BUN)

    Time frame: week0 and week8

  8. Uric Acid

    Time frame: week0 and week8

  9. Sodium (Na⁺)

    Time frame: week0 and week8

  10. Potassium (K⁺)

    Time frame: week0 and week8

  11. Free Fatty Acids (FFA)

    Time frame: week0 and week8

  12. Thyroid Stimulating Hormone (TSH)

    Time frame: week0 and week8

  13. white blood cell (WBC) count/automated differential

    Time frame: week0 and week8

  14. red blood cell (RBC) count

    Time frame: week0 and week8

  15. hemoglobin

    Time frame: week0 and week8

  16. hematocrit

    Time frame: week0 and week8

  17. platelet count

    Time frame: week0 and week8

  18. mean corpuscular volume (M.C.V)

    Time frame: week0 and week8

  19. mean corpuscular hemoglobin concentration (M.C.H.C)

    Time frame: week0 and week8

  20. total cholesterol (TC)

    Time frame: week0 and week8

  21. high-density lipoprotein cholesterol (HDL-C)non-HDL-C

    Time frame: week0 and week8

  22. low-density lipoprotein cholesterol (LDL-C)

    Time frame: week0 and week8

  23. triglycerides (TG)

    Time frame: week0 and week8

  24. glucose AC

    Time frame: week0 and week8

  25. Height

    Time frame: week0 , week4 and week8

  26. Weight

    Time frame: week0 , week4 and week8

  27. Body Mass Index (BMI)

    Time frame: week0 , week4 and week8

  28. Body Composition (muscle mass, fat mass, visceral fat level)

    Time frame: week0 , week4 and week8

  29. Hip Circumference

    Time frame: week0 , week4 and week8

  30. Waist-to-Hip Ratio (WHR)

    Time frame: week0 , week4 and week8

  31. Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))

    Time frame: week0, week8

  32. Next-Generation Sequencing (NGS)

    Time frame: week0 and week8

  33. Urinalysis

    Time frame: week0 and week8

  34. Dietary Record

    Time frame: week0 , week4 and week8

  35. Bowel Movement Record

    Time frame: week0 , week4 and week8

  36. Gastrointestinal Questionnaire

    Time frame: Week0 , week4 and week8

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Ta Yang, Professor

CONTACT

[email protected]

+886-2-27361661 ext. 2275

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Yung Shin Pharm. Ind. Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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