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Evaluation of RSB11-HI Postbiotic Supplementation for Supporting Weight Management, Metabolic Wellness, and Quality of Life in Healthy Adults

26 de agosto de 2026 actualizado por: Able Biolabs, LLC

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of RSB11-HI Postbiotic Supplementation for Supporting Weight Management, Metabolic Wellness, and Quality of Life in Healthy Adults

This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety, tolerability, and efficacy of RSB11-HI, a heat-inactivated postbiotic, in healthy adults over an 8-week intervention period. Participants will be classified into one of three predefined study populations-General Healthy, Perimenopausal, or Mild Inflammation-and will then be randomized within their assigned population to receive either RSB11-HI or placebo. The study will evaluate the effects of supplementation on healthy weight management, metabolic wellness, gastrointestinal health, and quality of life, while also exploring whether responses differ among the predefined study populations.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This 8-week, randomized, double-blind, placebo-controlled, decentralized clinical trial will evaluate the safety, tolerability, and efficacy of RSB11-HI, a heat-inactivated postbiotic derived from *Lactiplantibacillus plantarum* RSB11, in healthy adults. Following eligibility screening, participants will be classified into one of three predefined study populations-General Healthy, Perimenopausal, or Mild Inflammation-and randomized within their assigned population to receive RSB11-HI or placebo. The study will evaluate potential effects on healthy weight management, metabolic wellness, gastrointestinal health, and quality of life, while exploratory analyses will assess treatment responses across the predefined study populations.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos, 75247
        • Reclutamiento
        • Able Biolabs LLC
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Male or female, 18 to 55 years of age.
  • Body Mass Index (BMI) between 23 and 32 kg/m² at screening.
  • Able and willing to provide electronic informed consent.
  • Willing and able to comply with all study procedures and scheduled assessments.
  • Willing to maintain usual dietary habits and physical activity throughout the study period.
  • Access to a smartphone, tablet, or computer with reliable internet connectivity to complete remote study assessments.
  • Willing to refrain from initiating new dietary supplements, structured weight management programs, or significant lifestyle modifications intended to influence study outcomes during study participation.

Exclusion Criteria:

  • Participation in another interventional clinical study within 30 days prior to screening.
  • Current use of prescription medications intended for weight management.
  • Current use of probiotic or postbiotic supplements that cannot be discontinued at least 4 weeks prior to enrollment.
  • Antibiotic use within 4 weeks prior to screening.
  • Pregnancy, planned pregnancy during the study period, or breastfeeding.
  • Known allergy or hypersensitivity to any component of the investigational product or placebo.
  • History of any gastrointestinal condition, metabolic disorder, or other clinically significant medical condition that, in the opinion of the investigator, could interfere with study participation or interpretation of study results.
  • Any physical, psychological, or behavioral condition that, in the opinion of the investigator, would make participation unsafe or compromise compliance with the study protocol.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: RSB11-HI Heat-Inactivated Postbiotic
Participants assigned to this arm will receive RSB11-HI Heat-Inactivated Postbiotic orally once daily for 8 consecutive weeks according to the study dosing instructions.
Suplemento dietético: RSB11-HI Heat-Inactivated Postbiotic
RSB11-HI is a heat-inactivated postbiotic derived from Lactiplantibacillus plantarum RSB11. Participants will receive the assigned study product orally once daily for 8 consecutive weeks according to the study dosing instructions.
Comparador de placebos: Placebo
Participants assigned to this arm will receive the matched placebo orally once daily for 8 consecutive weeks according to the study dosing instructions. The placebo is identical in appearance, packaging, labeling, and administration schedule to the RSB11-HI study product to maintain blinding.
Otro: Placebo
Matched placebo administered orally once daily for 8 consecutive weeks. The placebo is identical in appearance, packaging, labeling, and administration schedule to the RSB11-HI study product to maintain blinding.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Weight From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
Change in body weight, measured in kilograms (kg), from Baseline (Week 0) to End of Study (Week 8). The change in body weight will be compared between the RSB11-HI and placebo groups.
Baseline to Week 8

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in BMI (kg/m²) from Baseline to Weeks 4 and 8.
Baseline, Week 4, and Week 8
Change in Waist Circumference
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in waist circumference from Baseline to Weeks 4 and 8.
Baseline, Week 4, and Week 8
Change in Appetite and Satiety
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in appetite and satiety as assessed using the Appetite Visual Analog Scale (VAS). The assessment includes four items evaluating current hunger, fullness, desire to eat, and prospective food consumption. Each item is rated from 0 to 100, with higher scores indicating a greater level of the sensation being assessed (e.g., greater hunger, greater fullness, greater desire to eat, or greater perceived capacity to eat).
Baseline, Week 4, and Week 8
Change in General Well-Being
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in general well-being as assessed using the World Health Organization Five Well-Being Index (WHO-5). The questionnaire consists of 5 items, each scored from 0 (At no time) to 5 (All of the time), resulting in a raw total score ranging from 0 to 25. Higher scores indicate better well-being.
Baseline, Week 4, and Week 8
Change in Perceived Stress
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in perceived stress as assessed using the 10-item Perceived Stress Scale (PSS-10). Each item is rated from 0 (Never) to 4 (Very Often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptoms
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The questionnaire contains 15 gastrointestinal symptom items, each rated from 1 (No discomfort) to 7 (Very severe discomfort). Item scores range from 1 to 7, with higher scores indicating greater gastrointestinal symptom severity.
Baseline, Week 4, and Week 8
Change in Menopause-Related Quality of Life
Periodo de tiempo: Baseline, Week 4, and Week 8
Change in menopause-related quality of life as assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL) in participants assigned to the Perimenopausal Wellness Population. The questionnaire assesses symptoms across vasomotor, psychosocial, physical, and sexual domains. For symptoms experienced, bother is rated from 0 (Not bothersome) to 6 (Extremely bothersome); participants may also indicate that a symptom was not experienced. Higher scores indicate greater symptom bother and worse menopause-related quality of life.
Baseline, Week 4, and Week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Able Biolabs, LLC

Investigadores

  • Investigador principal: Omkara Sai Kiran Pala, PharmD, Able Biolabs

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • RSB11-HI-001

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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