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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Texas
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Dallas, Texas, États-Unis, 75247
- Able Biolabs LLC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
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Inactivated supplement
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Expérimental: Supplément
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Active supplement
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline to Week 4 in PROMIS Physical Function T-score
Délai: Baseline and Week 4
|
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
Délai: 8 weeks
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8 weeks
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Change From Baseline to Week 4 in PROMIS Pain Interference T-score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline to Week 4 in Pain Intensity Numeric Rating Scale (NRS) Score
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies musculaires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur musculo-squelettique
- Limitation de la mobilité
- Nourriture
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Nourriture et boissons
- Suppléments alimentaires
Autres numéros d'identification d'étude
- ABL-032504
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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