A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial

Nutrition Journal

Wei Sha³  Mary Pat Meaney¹  Dustin Dew¹  Beibei Luo²  R Andrew Shanely¹  David C Nieman¹ 

[1] Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA;Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai, China;Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081, USA

关键词: Physical function;    Quality of life;    Inflammation;    Glucosamine;   

Others  :  802016
DOI  :  10.1186/1475-2891-12-154

 received in 2013-10-08, accepted in 2013-11-22,  发布年份 2013

【 摘 要 】

Background

The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement (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). Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs (NSAID) and all other medications and supplements targeted 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 9 plasma cytokines), and physical function (6-minute walk test). Joint pain symptom severity was assessed bi-weekly using a 12-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™ compared to 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 study

Conclusions

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 difficulty performing daily activities most apparent in subjects with knee pain.

Trial registration

ClinicalTrials.gov Identifier: NCT01956500

【 授权许可】

   
2013 Nieman et al.; licensee BioMed Central Ltd.

【 图 表 】

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