PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
26 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
140
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ming Ta Yang, Professor
- Número de telefone: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
Locais de estudo
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Taiwan
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Taipei, Taiwan, Taiwan, 110
- Recrutamento
- Taipei Medical University
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Contato:
- Ming Ta Yang, Professor
- Número de telefone: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
-
Taipei, Taiwan, Taiwan, 116
- Recrutamento
- Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
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Contato:
- Ming Ta Yang, Professor
- Número de telefone: 2275 +886-2-27361661
- E-mail: yangrugby@tmu.edu.tw
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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|
Experimental: 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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Comparador de Placebo: high-dose placebo group
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6 per day(Maltose powder, Aerosil, Magnesium Stearate)
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Comparador de Placebo: low-dose placebo group
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4 per day(Maltose powder, Aerosil, Magnesium Stearate)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Serum Ketone Bodies
Prazo: week0 and week8
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week0 and week8
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Albumin
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Week0 and week8
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Aspartate Aminotransferase (AST)
Prazo: week0 and week8
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week0 and week8
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Alanine Aminotransferase (ALT)
Prazo: week0 and week8
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week0 and week8
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Gamma-Glutamyl Transferase (GGT)
Prazo: week0 and week8
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week0 and week8
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Blood Creatinine
Prazo: week0 and week8
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week0 and week8
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Blood Urea Nitrogen (BUN)
Prazo: week0 and week8
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week0 and week8
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Uric Acid
Prazo: week0 and week8
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week0 and week8
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Sodium (Na⁺)
Prazo: week0 and week8
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week0 and week8
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Potassium (K⁺)
Prazo: week0 and week8
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week0 and week8
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Free Fatty Acids (FFA)
Prazo: week0 and week8
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week0 and week8
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Thyroid Stimulating Hormone (TSH)
Prazo: week0 and week8
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week0 and week8
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white blood cell (WBC) count/automated differential
Prazo: week0 and week8
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week0 and week8
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red blood cell (RBC) count
Prazo: week0 and week8
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week0 and week8
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hemoglobin
Prazo: week0 and week8
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week0 and week8
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hematocrit
Prazo: week0 and week8
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week0 and week8
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platelet count
Prazo: week0 and week8
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week0 and week8
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mean corpuscular volume (M.C.V)
Prazo: week0 and week8
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week0 and week8
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mean corpuscular hemoglobin concentration (M.C.H.C)
Prazo: week0 and week8
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week0 and week8
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total cholesterol (TC)
Prazo: week0 and week8
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week0 and week8
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high-density lipoprotein cholesterol (HDL-C)non-HDL-C
Prazo: week0 and week8
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week0 and week8
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low-density lipoprotein cholesterol (LDL-C)
Prazo: week0 and week8
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week0 and week8
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triglycerides (TG)
Prazo: week0 and week8
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week0 and week8
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glucose AC
Prazo: week0 and week8
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week0 and week8
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Height
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Weight
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Body Mass Index (BMI)
Prazo: 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)
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Hip Circumference
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Waist-to-Hip Ratio (WHR)
Prazo: 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))
Prazo: week0, week8
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week0, week8
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Next-Generation Sequencing (NGS)
Prazo: week0 and week8
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week0 and week8
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Urinalysis
Prazo: week0 and week8
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week0 and week8
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Dietary Record
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Bowel Movement Record
Prazo: week0 , week4 and week8
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week0 , week4 and week8
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Gastrointestinal Questionnaire
Prazo: Week0 , week4 and week8
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Week0 , week4 and week8
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de abril de 2026
Conclusão Primária (Estimado)
7 de abril de 2027
Conclusão do estudo (Estimado)
7 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- N202603016
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .