PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
26. mai 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-post: yangrugby@tmu.edu.tw
Studiesteder
-
-
Taiwan
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Taipei, Taiwan, Taiwan, 110
- Rekruttering
- Taipei Medical University
-
Ta kontakt med:
- Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-post: yangrugby@tmu.edu.tw
-
Taipei, Taiwan, Taiwan, 116
- Rekruttering
- Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
-
Ta kontakt med:
- Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-post: yangrugby@tmu.edu.tw
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: high-dose intervention group
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6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
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Eksperimentell: low-dose intervention group
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4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
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Placebo komparator: high-dose placebo group
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6 per day(Maltose powder, Aerosil, Magnesium Stearate)
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Placebo komparator: low-dose placebo group
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4 per day(Maltose powder, Aerosil, Magnesium Stearate)
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Hva måler studien?
Primære resultatmål
Resultatmål |
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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)
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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)
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Thyroid Stimulating Hormone (TSH)
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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)
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total cholesterol (TC)
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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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week0 and week8
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triglycerides (TG)
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glucose AC
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Height
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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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)
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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Hip Circumference
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week0 , week4 and week8
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Waist-to-Hip Ratio (WHR)
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))
Tidsramme: week0, week8
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week0, week8
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Next-Generation Sequencing (NGS)
Tidsramme: week0 and week8
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week0 and week8
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Urinalysis
Tidsramme: week0 and week8
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week0 and week8
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Dietary Record
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week0 , week4 and week8
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Bowel Movement Record
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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Gastrointestinal Questionnaire
Tidsramme: Week0 , week4 and week8
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Week0 , week4 and week8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. april 2026
Primær fullføring (Antatt)
7. april 2027
Studiet fullført (Antatt)
7. april 2027
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
26. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- N202603016
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .