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

26 maj 2026 uppdaterad av: Taipei Medical University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 110
        • Rekrytering
        • Taipei Medical University
        • Kontakt:
      • Taipei, Taiwan, Taiwan, 116
        • Rekrytering
        • Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: high-dose intervention group
Kosttillskott: 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)
Experimentell: low-dose intervention group
Kosttillskott: 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-jämförare: high-dose placebo group
Kosttillskott: Placebo group(High-dose)
6 per day(Maltose powder, Aerosil, Magnesium Stearate)
Placebo-jämförare: low-dose placebo group
Kosttillskott: Placebo group(Low-dose)
4 per day(Maltose powder, Aerosil, Magnesium Stearate)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Serum Ketone Bodies
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Albumin
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Aspartate Aminotransferase (AST)
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Alanine Aminotransferase (ALT)
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Gamma-Glutamyl Transferase (GGT)
Tidsram: week0 and week8
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Blood Creatinine
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Blood Urea Nitrogen (BUN)
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Uric Acid
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Sodium (Na⁺)
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Potassium (K⁺)
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Free Fatty Acids (FFA)
Tidsram: week0 and week8
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Thyroid Stimulating Hormone (TSH)
Tidsram: week0 and week8
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white blood cell (WBC) count/automated differential
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red blood cell (RBC) count
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hemoglobin
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hematocrit
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platelet count
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mean corpuscular volume (M.C.V)
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mean corpuscular hemoglobin concentration (M.C.H.C)
Tidsram: week0 and week8
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total cholesterol (TC)
Tidsram: week0 and week8
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high-density lipoprotein cholesterol (HDL-C)non-HDL-C
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low-density lipoprotein cholesterol (LDL-C)
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triglycerides (TG)
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glucose AC
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Height
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Weight
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Body Mass Index (BMI)
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Body Composition (muscle mass, fat mass, visceral fat level)
Tidsram: week0 , week4 and week8
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Hip Circumference
Tidsram: week0 , week4 and week8
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Waist-to-Hip Ratio (WHR)
Tidsram: week0 , week4 and week8
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Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))
Tidsram: week0, week8
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Next-Generation Sequencing (NGS)
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Urinalysis
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Dietary Record
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Bowel Movement Record
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Gastrointestinal Questionnaire
Tidsram: Week0 , week4 and week8
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Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Taipei Medical University

Samarbetspartners

Yung Shin Pharm. Ind. Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 april 2026

Primärt slutförande (Beräknad)

7 april 2027

Avslutad studie (Beräknad)

7 april 2027

Studieregistreringsdatum

Först inskickad

26 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • N202603016

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Nej

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