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

NCT07788833 | Recruiting

• 1 other identifier: RSB11-HI-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 8

Secondary Outcomes (7)

• Change in Body Mass Index (BMI)

  Baseline, Week 4, and Week 8

• Change in Waist Circumference

  Baseline, Week 4, and Week 8

• Change in Appetite and Satiety

  Baseline, Week 4, and Week 8

• Change in General Well-Being

  Baseline, Week 4, and Week 8

• Change in Perceived Stress

  Baseline, Week 4, and Week 8

Study Arms (2)

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.

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.

Other: Placebo

Interventions

RSB11-HI Heat-Inactivated Postbiotic DIETARY_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.

RSB11-HI Heat-Inactivated Postbiotic

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Able Biolabs, LLC: lead

Study Sites (1)

Able Biolabs LLC

Dallas, Texas, 75247, United States

RECRUITING

Study Officials

• Omkara Sai Kiran Pala, PharmD

  Able Biolabs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Coordinator

CONTACT

617-634-3675; clinical@ablebiolabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)