A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial
Bibliographic record
Abstract
Background-The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietarysupplement (InstaflexTM Joint Support, Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function in adults with self-reported joint pain. InstaflexTM is a joint pain supplement containing glucosamine sulfate, methylsufonlylmethane (MSM), white willow bark extract (15% salicin), ginger root concentrate, boswella serrata extract(65% boswellic acid), turmeric root extract, cayenne, and hyaluronic acid.Methods- Subjects included 100 men and women, ages 50-75 years, with a history (>3 months) of joint pain, and were randomized to Instaflex™ or placebo (3 colored gel capsules per day for 8 weeks, double-blind administration). Subjectsagreed to avoid the use of non-steroidal anti-inflammatory drugs (NSAID) and all other medications and supplementsmtargeted for joint pain. Primary outcome measures were obtained pre- and post-study and included joint pain severity,stiffness, and function (Western Ontario and McMaster Universities [WOMAC]), and secondary outcome measures included health-related quality of life (Short Form 36 or SF-36), systemic inflammation (serum C-reactive protein and 9plasma cytokines), and physical function (6-minute walk test). Joint pain symptom severity was assessed bi-weekly using a12-point Likert visual scale (12-VS).Results- Joint pain severity was significantly reduced in Instaflex™ compared to placebo (8-week WOMAC, ?37% versus?16%, respectively, interaction effect P=0.025), with group differences using the 12-VS emerging by week 4 of the study(interaction effect, P=0.0125). Improvements in ability to perform daily activities and stiffness scores in Instaflex™ comparedto placebo were most evident for the 74% of subjects reporting knee pain (8-week WOMAC function score, ?39% versus?14%, respectively, interaction effect P=0.027; stiffness score, ?30% versus ?12%, respectively, interaction effect P=0.081). Patterns of change in SF-36, systemic inflammation biomarkers, and the 6-minute walk test did not differ significantly between groups during the 8-week studyConclusions-Results from this randomized, double blind, placebo-controlled community trial support the use of the Instaflex™ dietary supplement in alleviating joint pain severity in middle-aged and older adults, with mitigation of difficultyperforming daily activities most apparent in subjects with knee pain.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.030 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.001 | 0.010 |
| Insufficient payload (model declined to judge) | 0.479 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; both teacher heads agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".