Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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. Successfully assigned to one predefined study population using the Study Population Classification Questionnaire (SPCQ). 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Able Biolabs LLC
Dallas, Texas 75247
Contact:
Clinical Trials Coordinator
617-634-3675
clinical@ablebiolabs.com

More Details

Status
Recruiting
Sponsor
Able Biolabs, LLC

Study Contact

Clinical Trials Coordinator
617-634-3675
clinical@ablebiolabs.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.