Health TrialsbyHealthPanel

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

ConditionHeathly Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaipei Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: high-dose intervention groupExperimental treatment 1 intervention
Group B: low-dose intervention groupExperimental treatment 1 intervention
Group C: high-dose placebo groupPlacebo comparator 1 intervention
Group D: low-dose placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Medical University

Lead sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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