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)

May 19, 2026 updated by: Able Biolabs, LLC

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75247
        • Able Biolabs LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Inactivated supplement
Experimental: Supplement
Active supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 4 in PROMIS Physical Function T-score
Time Frame: 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.
Baseline and Week 4
Changes in gut microbiota composition associated with bone health
Time Frame: 8 weeks
8 weeks
Change From Baseline to Week 4 in PROMIS Pain Interference T-score
Time Frame: Baseline and Week 4
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.
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 4 in Pain Intensity Numeric Rating Scale (NRS) Score
Time Frame: Baseline, weekly through Week 4, and Week 4
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Baseline, weekly through Week 4, and Week 4
Change From Baseline to Week 4 in Duke Activity Status Index (DASI) Score
Time Frame: Baseline and Week 4
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.
Baseline and Week 4
Change From Baseline to Week 4 in International Physical Activity Questionnaire-Short Form (IPAQ-SF) MET-minutes/week
Time Frame: Baseline and Week 4
IPAQ-SF assesses physical activity including walking, moderate activity, vigorous activity, and sedentary behavior. Results are expressed as MET-minutes per week.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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