Healthy Adults
Conditions
Keywords
RSB11-HI, Heat-Inactivated Postbiotic, Lactiplantibacillus plantarum, Metabolic Wellness, Weight Management, Gut Health, Appetite, Inflammatory Wellness, Dietary Supplement, Perimenopause
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.
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.
Interventions
DIETARY_SUPPLEMENTRSB11-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.
OTHERPlacebo
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.
Sponsors
Able Biolabs, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight From Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline, Week 4, and Week 8 | Change in BMI (kg/m²) from Baseline to Weeks 4 and 8. |
| Change in Waist Circumference | Baseline, Week 4, and Week 8 | Change in waist circumference from Baseline to Weeks 4 and 8. |
| Change in Appetite and Satiety | Baseline, Week 4, and Week 8 | 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 | Baseline, Week 4, and Week 8 | 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. |
| Change in Perceived Stress | Baseline, Week 4, and Week 8 | Change in perceived stress as assessed using the 10-item Perceived Stress Scale (PSS-10). Each item is rated from 0 (Never) to 4 (Very Often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. |
| Change in Gastrointestinal Symptoms | Baseline, Week 4, and Week 8 | Change in gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The questionnaire contains 15 gastrointestinal symptom items, each rated from 1 (No discomfort) to 7 (Very severe discomfort). Item scores range from 1 to 7, with higher scores indicating greater gastrointestinal symptom severity. |
| Change in Menopause-Related Quality of Life | Baseline, Week 4, and Week 8 | Change in menopause-related quality of life as assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL) in participants assigned to the Perimenopausal Wellness Population. The questionnaire assesses symptoms across vasomotor, psychosocial, physical, and sexual domains. For symptoms experienced, bother is rated from 0 (Not bothersome) to 6 (Extremely bothersome); participants may also indicate that a symptom was not experienced. Higher scores indicate greater symptom bother and worse menopause-related quality of life. |
Countries
United States
Contacts
CONTACTClinical Trials Coordinator
PRINCIPAL_INVESTIGATOROmkara Sai Kiran Pala, PharmD
Able Biolabs
Outcome results
None listed