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Recruiting NCT07618000

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

No phase Interventional Heathly Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PI-YSP-0111 formulation (High-dose), PI-YSP-0111 formulation (Low-dose), Placebo group(High-dose), Placebo group(Low-dose).
Who it may be relevant to
Registry conditions: Heathly Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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)
  • 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)
  • Dietary supplement Placebo group(High-dose)
    6 per day(Maltose powder, Aerosil, Magnesium Stearate)
  • Dietary supplement Placebo group(Low-dose)
    4 per day(Maltose powder, Aerosil, Magnesium Stearate)

Primary outcome measures

  • Serum Ketone Bodies [Time frame: week0 and week8]
  • Albumin [Time frame: Week0 and week8]
  • Aspartate Aminotransferase (AST) [Time frame: week0 and week8]
  • Alanine Aminotransferase (ALT) [Time frame: week0 and week8]
  • Gamma-Glutamyl Transferase (GGT) [Time frame: week0 and week8]
  • Blood Creatinine [Time frame: week0 and week8]
  • Blood Urea Nitrogen (BUN) [Time frame: week0 and week8]
  • Uric Acid [Time frame: week0 and week8]
  • Sodium (Na⁺) [Time frame: week0 and week8]
  • Potassium (K⁺) [Time frame: week0 and week8]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Taipei Medical University — Taipei
  • Taipei Municipal WanFang Hospital(Managed by Taipei Medical University) — Taipei

Identifiers

NCT: NCT07618000 · N202603016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗