A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial
Identifieur interne : 000B80 ( Pmc/Curation ); précédent : 000B79; suivant : 000B81A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial
Auteurs : David C. Nieman [États-Unis] ; R Andrew Shanely [États-Unis] ; Beibei Luo [République populaire de Chine] ; Dustin Dew [États-Unis] ; Mary Pat Meaney [États-Unis] ; Wei Sha [États-Unis]Source :
- Nutrition Journal [ 1475-2891 ] ; 2013.
Abstract
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.
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).
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
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.
ClinicalTrials.gov Identifier:
Url:
DOI: 10.1186/1475-2891-12-154
PubMed: 24274358
PubMed Central: 4176106
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Nieman</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Shanely, R Andrew" sort="Shanely, R Andrew" uniqKey="Shanely R" first="R Andrew" last="Shanely">R Andrew Shanely</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Luo, Beibei" sort="Luo, Beibei" uniqKey="Luo B" first="Beibei" last="Luo">Beibei Luo</name><affiliation wicri:level="1"><nlm:aff id="I2">Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Dew, Dustin" sort="Dew, Dustin" uniqKey="Dew D" first="Dustin" last="Dew">Dustin Dew</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Meaney, Mary Pat" sort="Meaney, Mary Pat" uniqKey="Meaney M" first="Mary Pat" last="Meaney">Mary Pat Meaney</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Sha, Wei" sort="Sha, Wei" uniqKey="Sha W" first="Wei" last="Sha">Wei Sha</name><affiliation wicri:level="1"><nlm:aff id="I3">Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24274358</idno><idno type="pmc">4176106</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176106</idno><idno type="RBID">PMC:4176106</idno><idno type="doi">10.1186/1475-2891-12-154</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000B81</idno><idno type="wicri:Area/Pmc/Curation">000B80</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial</title><author><name sortKey="Nieman, David C" sort="Nieman, David C" uniqKey="Nieman D" first="David C" last="Nieman">David C. Nieman</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Shanely, R Andrew" sort="Shanely, R Andrew" uniqKey="Shanely R" first="R Andrew" last="Shanely">R Andrew Shanely</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Luo, Beibei" sort="Luo, Beibei" uniqKey="Luo B" first="Beibei" last="Luo">Beibei Luo</name><affiliation wicri:level="1"><nlm:aff id="I2">Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai, China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai</wicri:regionArea></affiliation></author><author><name sortKey="Dew, Dustin" sort="Dew, Dustin" uniqKey="Dew D" first="Dustin" last="Dew">Dustin Dew</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Meaney, Mary Pat" sort="Meaney, Mary Pat" uniqKey="Meaney M" first="Mary Pat" last="Meaney">Mary Pat Meaney</name><affiliation wicri:level="1"><nlm:aff id="I1">Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081</wicri:regionArea></affiliation></author><author><name sortKey="Sha, Wei" sort="Sha, Wei" uniqKey="Sha W" first="Wei" last="Sha">Wei Sha</name><affiliation wicri:level="1"><nlm:aff id="I3">Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081</wicri:regionArea></affiliation></author></analytic><series><title level="j">Nutrition Journal</title><idno type="eISSN">1475-2891</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods</title><p>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).</p></sec><sec><title>Results</title><p>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</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/NCT01956500">NCT01956500</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Messier, Sp" uniqKey="Messier S">SP Messier</name></author><author><name sortKey="Loeser, Rf" uniqKey="Loeser R">RF Loeser</name></author><author><name sortKey="Miller, Gd" 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xml:lang="en"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Nutr J</journal-id><journal-id journal-id-type="iso-abbrev">Nutr J</journal-id><journal-title-group><journal-title>Nutrition Journal</journal-title></journal-title-group><issn pub-type="epub">1475-2891</issn><publisher><publisher-name>BioMed Central</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24274358</article-id><article-id pub-id-type="pmc">4176106</article-id><article-id pub-id-type="publisher-id">1475-2891-12-154</article-id><article-id pub-id-type="doi">10.1186/1475-2891-12-154</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes" id="A1"><name><surname>Nieman</surname><given-names>David C</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>niemandc@appstate.edu</email></contrib><contrib contrib-type="author" id="A2"><name><surname>Shanely</surname><given-names>R Andrew</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>shanelyra@appstate.edu</email></contrib><contrib contrib-type="author" id="A3"><name><surname>Luo</surname><given-names>Beibei</given-names></name><xref ref-type="aff" rid="I2">2</xref><email>lbb0220@126.com</email></contrib><contrib contrib-type="author" id="A4"><name><surname>Dew</surname><given-names>Dustin</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>dustindew@gmail.com</email></contrib><contrib contrib-type="author" id="A5"><name><surname>Meaney</surname><given-names>Mary Pat</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>mpmeaney@gmail.com</email></contrib><contrib contrib-type="author" id="A6"><name><surname>Sha</surname><given-names>Wei</given-names></name><xref ref-type="aff" rid="I3">3</xref><email>wsha@uncc.edu</email></contrib></contrib-group><aff id="I1"><label>1</label>Appalachian State University, Human Performance Lab, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081, USA</aff><aff id="I2"><label>2</label>Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, Shanghai, China</aff><aff id="I3"><label>3</label>Bioinformatics Services Division, University of North Carolina at Charlotte, North Carolina Research Campus, Kannapolis, NC 28081, USA</aff><pub-date pub-type="collection"><year>2013</year></pub-date><pub-date pub-type="epub"><day>25</day><month>11</month><year>2013</year></pub-date><volume>12</volume><fpage>154</fpage><lpage>154</lpage><history><date date-type="received"><day>8</day><month>10</month><year>2013</year></date><date date-type="accepted"><day>22</day><month>11</month><year>2013</year></date></history><permissions><copyright-statement>Copyright © 2013 Nieman et al.; licensee BioMed Central Ltd.</copyright-statement><copyright-year>2013</copyright-year><copyright-holder>Nieman et al.; licensee BioMed Central Ltd.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><self-uri xlink:href="http://www.nutritionj.com/content/12/1/154"></self-uri><abstract><sec><title>Background</title><p>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.</p></sec><sec><title>Methods</title><p>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).</p></sec><sec><title>Results</title><p>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</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/NCT01956500">NCT01956500</ext-link></p></sec></abstract><kwd-group><kwd>Glucosamine</kwd><kwd>Inflammation</kwd><kwd>Quality of life</kwd><kwd>Physical function</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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