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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Texas
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Dallas, Texas, Vereinigte Staaten, 75247
- Able Biolabs LLC
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: Placebo
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Inactivated supplement
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Experimental: Ergänzung
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Active supplement
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline to Week 4 in PROMIS Physical Function T-score
Zeitfenster: 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
Zeitfenster: 8 weeks
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8 weeks
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Change From Baseline to Week 4 in PROMIS Pain Interference T-score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline to Week 4 in Pain Intensity Numeric Rating Scale (NRS) Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Muskel-Skelett-Schmerzen
- Mobilitätseinschränkung
- Essen
- Ernährung, Nahrung und Ernährung
- Physiologische Phänomene
- Essen und Getränke
- Nahrungsergänzungsmittel
Andere Studien-ID-Nummern
- ABL-032504
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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