Healthy AdultsNCT07788833
Evaluation of RSB11-HI Postbiotic Supplementation for Supporting Weight Management, Metabolic Wellness, and Quality of Life in Healthy Adults
A study testing RSB11-HI Heat-Inactivated Postbiotic in people with Healthy Adults, run by Able Biolabs, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- RSB11-HI Heat-Inactivated Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Able Biolabs LLC
Dallas, Texas, 75247
Clinical Trials Coordinator, 617-634-3675, clinical@ablebiolabs.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- RSB11-HI Heat-Inactivated Postbiotic, Placebo
- Keywords
- RSB11-HI, Heat-Inactivated Postbiotic, Lactiplantibacillus plantarum, Metabolic Wellness, Weight Management, Gut Health, Appetite, Inflammatory Wellness, Dietary Supplement, Perimenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSB11-HI Heat-Inactivated PostbioticDietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RSB11-HI Heat-Inactivated Postbiotic | Experimental | 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. Receives: Dietary Supplement: RSB11-HI Heat-Inactivated Postbiotic |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight From 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.
Measured: Baseline to Week 8
Secondary outcomes (7)
Change in Body Mass Index (BMI)
Change in BMI (kg/m²) from Baseline to Weeks 4 and 8.
Measured: Baseline, Week 4, and Week 8
Change in Waist Circumference
Change in waist circumference from Baseline to Weeks 4 and 8.
Measured: Baseline, Week 4, and Week 8
Change in Appetite and Satiety
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).
Measured: Baseline, Week 4, and Week 8
Change in General Well-Being
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.
Measured: Baseline, Week 4, and Week 8
Change in Perceived Stress
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.
Measured: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptoms
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.
Measured: Baseline, Week 4, and Week 8
Change in Menopause-Related Quality of Life
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.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Able Biolabs, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omkara Sai Kiran Pala, PharmD, Principal investigator, Able Biolabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788833
- Sponsor's protocol ID
- RSB11-HI-001
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07788833
- Acronym / sponsor ID
- RSB11-HI-001
- Conditions
- Healthy Adults
- Keywords
- RSB11-HI, Heat-Inactivated Postbiotic, Lactiplantibacillus plantarum, Metabolic Wellness, Weight Management, Gut Health, Appetite, Inflammatory Wellness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Able Biolabs, LLCUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSB11-HI Heat-Inactivated Postbiotic | Experimental | Dietary Supplement: RSB11-HI Heat-Inactivated PostbioticParticipants assigned to this arm will receive RSB11-HI Heat-Inactivated Postbiotic orally once daily for 8 consecutive weeks according to the study dosing instructions. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSB11-HI Heat-Inactivated PostbioticRSB11-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. | Dietary supplement | RSB11-HI Heat-Inactivated Postbiotic |
| PlaceboMatched 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. | Other | Placebo |
Primary outcome
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.
7 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, Week 4, and Week 8
Change in Waist Circumference
Time frame: Baseline, Week 4, and Week 8
Change in Appetite and Satiety
Time frame: Baseline, Week 4, and Week 8
Change in General Well-Being
Time frame: Baseline, Week 4, and Week 8
Change in Perceived Stress
Time frame: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptoms
Time frame: Baseline, Week 4, and Week 8
Change in Menopause-Related Quality of Life
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omkara Sai Kiran Pala, PharmD principal investigator
Able Biolabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSB11-HI Heat-Inactivated Postbiotic in people with Healthy Adults, run by Able Biolabs, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Coordinator (617-634-3675, clinical@ablebiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight From Baseline to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.