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.
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.
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.
Parallel
RSB11-HI Heat-Inactivated Postbiotic
Dietary supplementRSB11-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
Other interventionMatched 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.
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.
Change in Body Mass Index (BMI)
Change in BMI (kg/m²) from Baseline to Weeks 4 and 8.
Change in Waist Circumference
Change in waist circumference from Baseline to Weeks 4 and 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).
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.
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