Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

26. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: 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.
Placebo-Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Weight From Baseline to Week 8
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Mass Index (BMI)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Able Biolabs, LLC

Ermittler

  • Hauptermittler: Omkara Sai Kiran Pala, PharmD, Able Biolabs

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. November 2026

Studienanmeldedaten

Zuerst eingereicht

24. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. August 2026

Zuerst gepostet (Tatsächlich)

27. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • RSB11-HI-001

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren