Recruiting

RSB11-HI

Sponsor:

Able Biolabs, LLC

Code:

NCT07788833

Conditions

Healthy Adults

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

RSB11-HI Heat-Inactivated Postbiotic

Placebo

Study Details

Brief 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. 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.

Conditions

Healthy Adults

Study ID

NCT07788833

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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.

Primary outcome measure

  • Change in Body Weight From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

Central Contacts and Locations

Central contacts

Clinical Trials Coordinator

617-634-3675clinical@ablebiolabs.com

Locations

Able Biolabs LLC

Recruiting

Dallas, Texas, United States, 75247

Contacts

Clinical Trials Coordinator

617-634-3675clinical@ablebiolabs.com

More Information

Sponsor

Able Biolabs, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • RSB11-HI
  • Heat-Inactivated Postbiotic
  • Lactiplantibacillus plantarum
  • Metabolic Wellness
  • Weight Management
  • Gut Health
  • Appetite
  • Inflammatory Wellness
  • Dietary Supplement
  • Perimenopause

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Able Biolabs, LLC on 2026-08-28.