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

26 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Texas
      • Dallas, Texas, États-Unis, 75247
        • Recrutement
        • Able Biolabs LLC
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: 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.
Comparateur placebo: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Body Weight From Baseline to Week 8
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Body Mass Index (BMI)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Able Biolabs, LLC

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

24 août 2026

Première publication (Réel)

27 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • RSB11-HI-001

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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