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

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.

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.

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.