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

August 26, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: 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 Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight From Baseline to Week 8
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Able Biolabs, LLC

Investigators

  • Principal Investigator: Omkara Sai Kiran Pala, PharmD, Able Biolabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSB11-HI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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