Evaluation of RSB11-HI Postbiotic Supplementation for Supporting Weight Management, Metabolic Wellness, and Quality of Life in Healthy Adults
2026年8月26日 更新者：Able Biolabs, LLC
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Trials Coordinator
- 电话号码：617-634-3675
- 邮箱：clinical@ablebiolabs.com
学习地点
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Texas
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Dallas、Texas、美国、75247
- 招聘中
- Able Biolabs LLC
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接触：
- Clinical Trials Coordinator
- 电话号码：617-634-3675
- 邮箱：clinical@ablebiolabs.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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安慰剂比较：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Body Weight From Baseline to Week 8
大体时间：Baseline to Week 8
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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.
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Baseline to Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Body Mass Index (BMI)
大体时间：Baseline, Week 4, and Week 8
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Change in BMI (kg/m²) from Baseline to Weeks 4 and 8.
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Baseline, Week 4, and Week 8
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Change in Waist Circumference
大体时间：Baseline, Week 4, and Week 8
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Change in waist circumference from Baseline to Weeks 4 and 8.
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Baseline, Week 4, and Week 8
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Change in Appetite and Satiety
大体时间：Baseline, Week 4, and Week 8
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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).
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Baseline, Week 4, and Week 8
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Change in General Well-Being
大体时间：Baseline, Week 4, and Week 8
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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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Baseline, Week 4, and Week 8
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Change in Perceived Stress
大体时间：Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Change in Gastrointestinal Symptoms
大体时间：Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Change in Menopause-Related Quality of Life
大体时间：Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Omkara Sai Kiran Pala, PharmD、Able Biolabs
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年11月1日
研究注册日期
首次提交
2026年8月24日
首先提交符合 QC 标准的
2026年8月24日
首次发布 (实际的)
2026年8月27日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- RSB11-HI-001
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.