Prebiotic formulation and its effects on gut microbiota and body composition in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will compare high- and low-dose PI-YSP-0111 against placebo over 8 weeks in healthy adults aged 18–65. Participants will provide blood, urine, and fecal samples at baseline and after 8 weeks, with body composition and questionnaires assessed at baseline, 4 weeks, and 8 weeks. Data will be analyzed with a two-way mixed-design ANOVA to explore differences between and within groups. The trial is conducted at Taipei Medical University and Taipei Municipal WanFang Hospital in Taiwan, sponsored by Taipei Medical University with collaboration from Yung Shin Pharmaceutical Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Medical University
  Taipei, Taiwan, Taiwan Recruiting
• Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
  Taipei, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Ming Ta Yang, Professor
• Email: yangrugby@tmu.edu.tw
• Phone: +886-2-27361661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.