A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of resO™ Bone and Joint Support Postbiotic on Physical Function, Pain Interference, and Mobility in Adults With Joint Discomfort (RESO101)
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of a Postbiotic Supplement (resO) on Bone Health and Activity
This randomized, double-blind, placebo-controlled study evaluates the effects of resO™ Bone and Joint Support Postbiotic on physical function, pain interference, mobility, and recovery in adults aged 18-75 years experiencing joint discomfort, stiffness, or reduced mobility.
Participants will be randomized to receive either resO™ or placebo for 4 weeks. Outcomes will be assessed using validated patient-reported outcome measures, including PROMIS Physical Function, PROMIS Pain Interference, Duke Activity Status Index (DASI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), and pain numeric rating scales.
The primary objective is to evaluate whether resO™ improves physical function and reduces pain interference compared with placebo.
調査の概要
詳細な説明
Joint discomfort and reduced mobility are associated with impaired physical function, pain interference, and decreased quality of life. Chronic low-grade inflammation and connective tissue degeneration contribute to limitations in daily activities and recovery.
This study evaluates resO™ Bone and Joint Support Postbiotic, a microbiome-informed supplement containing heat-inactivated Lactiplantibacillus plantarum RSB11® HI combined with glucosamine sulfate, chondroitin sulfate, methylsulfonylmethane (MSM), Boswellia serrata extract, curcumin extract, bromelain, and vitamin D3.
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study conducted remotely using electronic data capture. Approximately 40 participants aged 18-75 years with self-reported joint discomfort, stiffness, or reduced mobility will be randomized 1:1 to receive either resO™ or placebo for 4 weeks.
Primary endpoints include changes from baseline to Week 4 in:
PROMIS Physical Function T-score PROMIS Pain Interference T-score
Secondary endpoints include:
Pain intensity Numeric Rating Scale (NRS) Duke Activity Status Index (DASI) International Physical Activity Questionnaire-Short Form (IPAQ-SF) Activity limitation assessments Musculoskeletal recovery assessments Rescue medication use
Safety and tolerability will be assessed through adverse event monitoring and gastrointestinal tolerability questionnaires.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75247
- Able Biolabs LLC
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria
Provide voluntary signed informed consent Adults aged 18-75 years Self-reported joint discomfort, stiffness, or reduced mobility affecting daily activities In generally good health based on self-reported medical history Agree to maintain stable diet, exercise, and lifestyle patterns throughout the study Able and willing to comply with study procedures and electronic questionnaires Access to smartphone, tablet, or computer with internet access
Exclusion Criteria
Chronic inflammatory or autoimmune joint disease requiring immunosuppressive or biologic therapy Recent joint surgery or significant musculoskeletal injury within the past 3 months Current unstable use of prescription medications intended for joint pain or inflammation Regular use of joint-targeting supplements that cannot be discontinued prior to participation Known allergy or intolerance to study product ingredients Participation in another investigational study within the past 30 days Pregnant, planning pregnancy, or breastfeeding Significant uncontrolled medical condition that may interfere with study participation or interpretation of results Inability or unwillingness to comply with study procedures
研究計画
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：支持療法
- 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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プラセボコンパレーター：プラセボ
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Inactivated supplement
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実験的：補足
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Active supplement
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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 |
|---|---|---|
|
Change From Baseline to Week 4 in PROMIS Physical Function T-score
時間枠：Baseline and Week 4
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PROMIS Physical Function Adult Short Form is a validated patient-reported outcome measure assessing physical functioning including walking, climbing stairs, bending, and carrying objects.
Scores are standardized as T-scores with a population mean of 50 and standard deviation of 10.
Higher scores indicate better physical function.
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Baseline and Week 4
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Changes in gut microbiota composition associated with bone health
時間枠：8 weeks
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8 weeks
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Change From Baseline to Week 4 in PROMIS Pain Interference T-score
時間枠：Baseline and Week 4
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PROMIS Pain Interference Adult Short Form is a validated patient-reported outcome measure assessing the extent to which pain interferes with daily activities, social participation, and quality of life.
Scores are standardized as T-scores with a population mean of 50 and standard deviation of 10.
Higher scores indicate greater pain interference.
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Baseline and Week 4
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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 From Baseline to Week 4 in Pain Intensity Numeric Rating Scale (NRS) Score
時間枠：Baseline, weekly through Week 4, and Week 4
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Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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Baseline, weekly through Week 4, and Week 4
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Change From Baseline to Week 4 in Duke Activity Status Index (DASI) Score
時間枠：Baseline and Week 4
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The Duke Activity Status Index (DASI) is a validated questionnaire assessing functional capacity and activities of daily living.
Scores range from 0 to 58.2, with higher scores indicating greater functional capacity.
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Baseline and Week 4
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Change From Baseline to Week 4 in International Physical Activity Questionnaire-Short Form (IPAQ-SF) MET-minutes/week
時間枠：Baseline and Week 4
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IPAQ-SF assesses physical activity including walking, moderate activity, vigorous activity, and sedentary behavior.
Results are expressed as MET-minutes per week.
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Baseline and Week 4
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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