PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
26. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
Studiesteder
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 110
- Rekruttering
- Taipei Medical University
-
Kontakt:
- Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
-
Taipei, Taiwan, Taiwan, 116
- Rekruttering
- Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
-
Kontakt:
- Ming Ta Yang, Professor
- Telefonnummer: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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|
Eksperimentel: 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)
|
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Serum Ketone Bodies
Tidsramme: week0 and week8
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week0 and week8
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Albumin
Tidsramme: Week0 and week8
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Week0 and week8
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Aspartate Aminotransferase (AST)
Tidsramme: week0 and week8
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week0 and week8
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Alanine Aminotransferase (ALT)
Tidsramme: week0 and week8
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week0 and week8
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Gamma-Glutamyl Transferase (GGT)
Tidsramme: week0 and week8
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week0 and week8
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Blood Creatinine
Tidsramme: week0 and week8
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week0 and week8
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Blood Urea Nitrogen (BUN)
Tidsramme: week0 and week8
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week0 and week8
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Uric Acid
Tidsramme: week0 and week8
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week0 and week8
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Sodium (Na⁺)
Tidsramme: week0 and week8
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week0 and week8
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Potassium (K⁺)
Tidsramme: week0 and week8
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week0 and week8
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Free Fatty Acids (FFA)
Tidsramme: week0 and week8
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week0 and week8
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Thyroid Stimulating Hormone (TSH)
Tidsramme: week0 and week8
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week0 and week8
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white blood cell (WBC) count/automated differential
Tidsramme: week0 and week8
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week0 and week8
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red blood cell (RBC) count
Tidsramme: week0 and week8
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week0 and week8
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hemoglobin
Tidsramme: week0 and week8
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week0 and week8
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hematocrit
Tidsramme: week0 and week8
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week0 and week8
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platelet count
Tidsramme: week0 and week8
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week0 and week8
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mean corpuscular volume (M.C.V)
Tidsramme: week0 and week8
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week0 and week8
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mean corpuscular hemoglobin concentration (M.C.H.C)
Tidsramme: week0 and week8
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week0 and week8
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total cholesterol (TC)
Tidsramme: week0 and week8
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week0 and week8
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high-density lipoprotein cholesterol (HDL-C)non-HDL-C
Tidsramme: week0 and week8
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week0 and week8
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low-density lipoprotein cholesterol (LDL-C)
Tidsramme: week0 and week8
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week0 and week8
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triglycerides (TG)
Tidsramme: week0 and week8
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week0 and week8
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glucose AC
Tidsramme: week0 and week8
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week0 and week8
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Height
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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Weight
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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Body Mass Index (BMI)
Tidsramme: week0 , week4 and week8
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week0 , week4 and week8
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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
Tidsramme: week0 , week4 and week8
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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
|
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
Tidsramme: week0 , week4 and week8
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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
|
Week0 , week4 and week8
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. april 2026
Primær færdiggørelse (Anslået)
7. april 2027
Studieafslutning (Anslået)
7. april 2027
Datoer for studieregistrering
Først indsendt
26. maj 2026
Først indsendt, der opfyldte QC-kriterier
26. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- N202603016
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .