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

N/AActive Not RecruitingNCT07602426

Able Biolabs, LLC40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline to Week 4 in PROMIS Physical Function T-score

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.

Time frame: Baseline and Week 4

Changes in gut microbiota composition associated with bone health

Time frame: 8 weeks

Change From Baseline to Week 4 in PROMIS Pain Interference T-score

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.

Time frame: Baseline and Week 4

Secondary Outcomes

Change From Baseline to Week 4 in Pain Intensity Numeric Rating Scale (NRS) Score

Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Time frame: Baseline, weekly through Week 4, and Week 4

Change From Baseline to Week 4 in Duke Activity Status Index (DASI) Score

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.

Time frame: Baseline and Week 4

Change From Baseline to Week 4 in International Physical Activity Questionnaire-Short Form (IPAQ-SF) MET-minutes/week

IPAQ-SF assesses physical activity including walking, moderate activity, vigorous activity, and sedentary behavior. Results are expressed as MET-minutes per week.

Time frame: Baseline and Week 4

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes