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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clinical Trials Coordinator
- 電話番号：617-634-3675
- メール：clinical@ablebiolabs.com
研究場所
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Texas
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Dallas、Texas、アメリカ、75247
- 募集
- Able Biolabs LLC
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コンタクト：
- Clinical Trials Coordinator
- 電話番号：617-634-3675
- メール：clinical@ablebiolabs.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Weight From Baseline to Week 8
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Mass Index (BMI)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Omkara Sai Kiran Pala, PharmD、Able Biolabs
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2026年11月1日
試験登録日
最初に提出
2026年8月24日
QC基準を満たした最初の提出物
2026年8月24日
最初の投稿 (実際)
2026年8月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RSB11-HI-001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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