ω-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial
Older adults with lower intake and tissue levels of long-chain ω-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6) have more brain white matter lesions (WMLs), an association suggesting that small-vessel ischemic disease, a major contributor...
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| creator | Shinto, Lynne H Murchison, Charles F Silbert, Lisa C Dodge, Hiroko H Lahna, David Rooney, William Kaye, Jeffrey Quinn, Joseph F Bowman, Gene L |
| description | Older adults with lower intake and tissue levels of long-chain ω-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6) have more brain white matter lesions (WMLs), an association suggesting that small-vessel ischemic disease, a major contributor to the development of dementia, including Alzheimer disease, may be preventable through ω-3 treatment.
To determine whether ω-3 treatment reduces WML accumulation in older adults without dementia harboring WMLs and with suboptimal ω-3 status.
This quadruple-blinded, placebo-controlled, randomized clinical trial with treatment stratification by apolipoprotein E ε4 allele (APOE*E4) carrier status used linear mixed-effects models to estimate mean annual change between groups. The study was conducted at Oregon Health & Science University, a major academic medical center in the Pacific Northwest, from May 2014 to final participant visit in September 2019. Data analysis concluded in July 2022. Participants were adults without dementia aged 75 years and older with WMLs greater than or equal to 5 cm3 and plasma ω-3 PUFA less than 5.5 weight percentage of total.
Three-year treatment with 1.65 g of ω-3 PUFA (975 mg of EPA and 650 mg of DHA) vs a soybean oil placebo matched for taste, smell, and appearance.
The primary outcome was annual WML progression measured using magnetic resonance imaging. Secondary outcomes included diffusion tensor imaging of fractional anisotropy (DTI-FA), representing neuronal integrity breakdown.
A total of 102 participants (62 women [60.8%]; mean age, 81 years [range, 75-96 years]) were equally randomized, 51 per treatment group. Although the ω-3 group had less annual WML accumulation than the placebo group, the difference was not statistically significant (1.19 cm3 [95% CI, 0.64-1.74 cm3] vs 1.34 cm3 [95% CI, 0.80-1.88 cm3]; P = .30). Similarly, the ω-3 group had less annual DTI-FA decline than the placebo group, but the difference was not statistically significant (-0.0014 mm2/s [95% CI, -0.0027 to 0.0002 mm2/s] vs -0.0027 mm2/s [95% CI, -0.0041 to -0.0014 mm2/s]; P = .07). Among APOE*E4 carriers, the annual DTI-FA decline was significantly lower in the group treated with ω-3 than the placebo group (-0.0016 mm2/s [95% CI, -0.0032 to 0.0020 mm2/s] vs -0.0047 mm2/s [95% CI, -0.0067 to -0.0025 mm2/s]; P = .04). Adverse events were similar between treatment groups.
In this 3-year randomized clinical trial, ω-3 treatment was safe and well-tolerat |
| doi_str_mv | 10.1001/jamanetworkopen.2024.26872 |
| format | Article |
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To determine whether ω-3 treatment reduces WML accumulation in older adults without dementia harboring WMLs and with suboptimal ω-3 status.
This quadruple-blinded, placebo-controlled, randomized clinical trial with treatment stratification by apolipoprotein E ε4 allele (APOE*E4) carrier status used linear mixed-effects models to estimate mean annual change between groups. The study was conducted at Oregon Health & Science University, a major academic medical center in the Pacific Northwest, from May 2014 to final participant visit in September 2019. Data analysis concluded in July 2022. Participants were adults without dementia aged 75 years and older with WMLs greater than or equal to 5 cm3 and plasma ω-3 PUFA less than 5.5 weight percentage of total.
Three-year treatment with 1.65 g of ω-3 PUFA (975 mg of EPA and 650 mg of DHA) vs a soybean oil placebo matched for taste, smell, and appearance.
The primary outcome was annual WML progression measured using magnetic resonance imaging. Secondary outcomes included diffusion tensor imaging of fractional anisotropy (DTI-FA), representing neuronal integrity breakdown.
A total of 102 participants (62 women [60.8%]; mean age, 81 years [range, 75-96 years]) were equally randomized, 51 per treatment group. Although the ω-3 group had less annual WML accumulation than the placebo group, the difference was not statistically significant (1.19 cm3 [95% CI, 0.64-1.74 cm3] vs 1.34 cm3 [95% CI, 0.80-1.88 cm3]; P = .30). Similarly, the ω-3 group had less annual DTI-FA decline than the placebo group, but the difference was not statistically significant (-0.0014 mm2/s [95% CI, -0.0027 to 0.0002 mm2/s] vs -0.0027 mm2/s [95% CI, -0.0041 to -0.0014 mm2/s]; P = .07). Among APOE*E4 carriers, the annual DTI-FA decline was significantly lower in the group treated with ω-3 than the placebo group (-0.0016 mm2/s [95% CI, -0.0032 to 0.0020 mm2/s] vs -0.0047 mm2/s [95% CI, -0.0067 to -0.0025 mm2/s]; P = .04). Adverse events were similar between treatment groups.
In this 3-year randomized clinical trial, ω-3 treatment was safe and well-tolerated but failed to reach significant reductions in WML accumulation or neuronal integrity breakdown among all participants, which may be attributable to sample size limitations. However, neuronal integrity breakdown was reduced by ω-3 treatment in APOE*E4 carriers, suggesting that this treatment may be beneficial for this specific group.
ClinicalTrials.gov Identifier: NCT01953705.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>DOI: 10.1001/jamanetworkopen.2024.26872</identifier><identifier>PMID: 39088212</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Aged ; Aged, 80 and over ; Clinical trials ; Dementia ; Docosahexaenoic Acids - pharmacology ; Docosahexaenoic Acids - therapeutic use ; Eicosapentaenoic Acid - pharmacology ; Eicosapentaenoic Acid - therapeutic use ; Fatty Acids, Omega-3 - therapeutic use ; Female ; Humans ; Magnetic Resonance Imaging - methods ; Male ; Neurology ; Older people ; Online Only ; Original Investigation ; Polyunsaturated fatty acids ; Secondary Prevention - methods ; White Matter - diagnostic imaging ; White Matter - drug effects ; White Matter - pathology</subject><ispartof>JAMA network open, 2024-08, Vol.7 (8), p.e2426872</ispartof><rights>2024. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright 2024 Shinto LH et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a295t-ab480699849b144378e9449558503915d0fcece4445c9c514595790aee3c67a33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,860,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39088212$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shinto, Lynne H</creatorcontrib><creatorcontrib>Murchison, Charles F</creatorcontrib><creatorcontrib>Silbert, Lisa C</creatorcontrib><creatorcontrib>Dodge, Hiroko H</creatorcontrib><creatorcontrib>Lahna, David</creatorcontrib><creatorcontrib>Rooney, William</creatorcontrib><creatorcontrib>Kaye, Jeffrey</creatorcontrib><creatorcontrib>Quinn, Joseph F</creatorcontrib><creatorcontrib>Bowman, Gene L</creatorcontrib><title>ω-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial</title><title>JAMA network open</title><addtitle>JAMA Netw Open</addtitle><description>Older adults with lower intake and tissue levels of long-chain ω-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6) have more brain white matter lesions (WMLs), an association suggesting that small-vessel ischemic disease, a major contributor to the development of dementia, including Alzheimer disease, may be preventable through ω-3 treatment.
To determine whether ω-3 treatment reduces WML accumulation in older adults without dementia harboring WMLs and with suboptimal ω-3 status.
This quadruple-blinded, placebo-controlled, randomized clinical trial with treatment stratification by apolipoprotein E ε4 allele (APOE*E4) carrier status used linear mixed-effects models to estimate mean annual change between groups. The study was conducted at Oregon Health & Science University, a major academic medical center in the Pacific Northwest, from May 2014 to final participant visit in September 2019. Data analysis concluded in July 2022. Participants were adults without dementia aged 75 years and older with WMLs greater than or equal to 5 cm3 and plasma ω-3 PUFA less than 5.5 weight percentage of total.
Three-year treatment with 1.65 g of ω-3 PUFA (975 mg of EPA and 650 mg of DHA) vs a soybean oil placebo matched for taste, smell, and appearance.
The primary outcome was annual WML progression measured using magnetic resonance imaging. Secondary outcomes included diffusion tensor imaging of fractional anisotropy (DTI-FA), representing neuronal integrity breakdown.
A total of 102 participants (62 women [60.8%]; mean age, 81 years [range, 75-96 years]) were equally randomized, 51 per treatment group. Although the ω-3 group had less annual WML accumulation than the placebo group, the difference was not statistically significant (1.19 cm3 [95% CI, 0.64-1.74 cm3] vs 1.34 cm3 [95% CI, 0.80-1.88 cm3]; P = .30). Similarly, the ω-3 group had less annual DTI-FA decline than the placebo group, but the difference was not statistically significant (-0.0014 mm2/s [95% CI, -0.0027 to 0.0002 mm2/s] vs -0.0027 mm2/s [95% CI, -0.0041 to -0.0014 mm2/s]; P = .07). Among APOE*E4 carriers, the annual DTI-FA decline was significantly lower in the group treated with ω-3 than the placebo group (-0.0016 mm2/s [95% CI, -0.0032 to 0.0020 mm2/s] vs -0.0047 mm2/s [95% CI, -0.0067 to -0.0025 mm2/s]; P = .04). Adverse events were similar between treatment groups.
In this 3-year randomized clinical trial, ω-3 treatment was safe and well-tolerated but failed to reach significant reductions in WML accumulation or neuronal integrity breakdown among all participants, which may be attributable to sample size limitations. However, neuronal integrity breakdown was reduced by ω-3 treatment in APOE*E4 carriers, suggesting that this treatment may be beneficial for this specific group.
ClinicalTrials.gov Identifier: NCT01953705.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Clinical trials</subject><subject>Dementia</subject><subject>Docosahexaenoic Acids - pharmacology</subject><subject>Docosahexaenoic Acids - therapeutic use</subject><subject>Eicosapentaenoic Acid - pharmacology</subject><subject>Eicosapentaenoic Acid - therapeutic use</subject><subject>Fatty Acids, Omega-3 - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Male</subject><subject>Neurology</subject><subject>Older people</subject><subject>Online Only</subject><subject>Original Investigation</subject><subject>Polyunsaturated fatty acids</subject><subject>Secondary Prevention - methods</subject><subject>White Matter - diagnostic imaging</subject><subject>White Matter - drug effects</subject><subject>White Matter - pathology</subject><issn>2574-3805</issn><issn>2574-3805</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkd9OFDEYxSdGIwR5BdPojTez9v9MuTHLRpRkFaIQL5tu5xvoMtOubQeCT6BP5ytZBAly1S_tOSc936-qXhE8IxiTt2szGg_5KsSLsAE_o5jyGZVtQ59U21Q0vGYtFk8fzFvVbkprjDHFhCkpnldbTOG2pYRuVz9__6oZOj49mKM-RPQVbPCdidfoOMIl-OyCR6FH385dBvTJ5AwRLSGV64SM79BnmGLwZkCHPsNZdPka7UcwF1248sh5dDR0xTHvpiGnPTRHX4opjO4HdGgxOO9ssZ5EZ4YX1bPeDAl2786d6vTg_cniY708-nC4mC9rQ5XItVnxFkulWq5WhHPWtKA4V0K0AjNFRId7CxY458IqKwgXSjQKGwBmZWMY26ne3eZuptUInS0doxn0Jrqx1NbBOP3_i3fn-ixcakKo4krKkvDmLiGG7xOkrEeXLAxD4RKmpBlupRKywU2Rvn4kXYcplnUVFeFUcNkoUlR7tyobQ0oR-vvfEKxvoOtH0PUNdP0XejG_fNjn3voPMfsDgW2t_Q</recordid><startdate>20240801</startdate><enddate>20240801</enddate><creator>Shinto, Lynne H</creator><creator>Murchison, Charles F</creator><creator>Silbert, Lisa C</creator><creator>Dodge, Hiroko H</creator><creator>Lahna, David</creator><creator>Rooney, William</creator><creator>Kaye, Jeffrey</creator><creator>Quinn, Joseph F</creator><creator>Bowman, Gene L</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20240801</creationdate><title>ω-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial</title><author>Shinto, Lynne H ; Murchison, Charles F ; Silbert, Lisa C ; Dodge, Hiroko H ; Lahna, David ; Rooney, William ; Kaye, Jeffrey ; Quinn, Joseph F ; Bowman, Gene L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a295t-ab480699849b144378e9449558503915d0fcece4445c9c514595790aee3c67a33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Clinical trials</topic><topic>Dementia</topic><topic>Docosahexaenoic Acids - pharmacology</topic><topic>Docosahexaenoic Acids - therapeutic use</topic><topic>Eicosapentaenoic Acid - pharmacology</topic><topic>Eicosapentaenoic Acid - therapeutic use</topic><topic>Fatty Acids, Omega-3 - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Male</topic><topic>Neurology</topic><topic>Older people</topic><topic>Online Only</topic><topic>Original Investigation</topic><topic>Polyunsaturated fatty acids</topic><topic>Secondary Prevention - methods</topic><topic>White Matter - diagnostic imaging</topic><topic>White Matter - drug effects</topic><topic>White Matter - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shinto, Lynne H</creatorcontrib><creatorcontrib>Murchison, Charles F</creatorcontrib><creatorcontrib>Silbert, Lisa C</creatorcontrib><creatorcontrib>Dodge, Hiroko H</creatorcontrib><creatorcontrib>Lahna, David</creatorcontrib><creatorcontrib>Rooney, William</creatorcontrib><creatorcontrib>Kaye, Jeffrey</creatorcontrib><creatorcontrib>Quinn, Joseph F</creatorcontrib><creatorcontrib>Bowman, Gene L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA network open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shinto, Lynne H</au><au>Murchison, Charles F</au><au>Silbert, Lisa C</au><au>Dodge, Hiroko H</au><au>Lahna, David</au><au>Rooney, William</au><au>Kaye, Jeffrey</au><au>Quinn, Joseph F</au><au>Bowman, Gene L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>ω-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial</atitle><jtitle>JAMA network open</jtitle><addtitle>JAMA Netw Open</addtitle><date>2024-08-01</date><risdate>2024</risdate><volume>7</volume><issue>8</issue><spage>e2426872</spage><pages>e2426872-</pages><issn>2574-3805</issn><eissn>2574-3805</eissn><abstract>Older adults with lower intake and tissue levels of long-chain ω-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6) have more brain white matter lesions (WMLs), an association suggesting that small-vessel ischemic disease, a major contributor to the development of dementia, including Alzheimer disease, may be preventable through ω-3 treatment.
To determine whether ω-3 treatment reduces WML accumulation in older adults without dementia harboring WMLs and with suboptimal ω-3 status.
This quadruple-blinded, placebo-controlled, randomized clinical trial with treatment stratification by apolipoprotein E ε4 allele (APOE*E4) carrier status used linear mixed-effects models to estimate mean annual change between groups. The study was conducted at Oregon Health & Science University, a major academic medical center in the Pacific Northwest, from May 2014 to final participant visit in September 2019. Data analysis concluded in July 2022. Participants were adults without dementia aged 75 years and older with WMLs greater than or equal to 5 cm3 and plasma ω-3 PUFA less than 5.5 weight percentage of total.
Three-year treatment with 1.65 g of ω-3 PUFA (975 mg of EPA and 650 mg of DHA) vs a soybean oil placebo matched for taste, smell, and appearance.
The primary outcome was annual WML progression measured using magnetic resonance imaging. Secondary outcomes included diffusion tensor imaging of fractional anisotropy (DTI-FA), representing neuronal integrity breakdown.
A total of 102 participants (62 women [60.8%]; mean age, 81 years [range, 75-96 years]) were equally randomized, 51 per treatment group. Although the ω-3 group had less annual WML accumulation than the placebo group, the difference was not statistically significant (1.19 cm3 [95% CI, 0.64-1.74 cm3] vs 1.34 cm3 [95% CI, 0.80-1.88 cm3]; P = .30). Similarly, the ω-3 group had less annual DTI-FA decline than the placebo group, but the difference was not statistically significant (-0.0014 mm2/s [95% CI, -0.0027 to 0.0002 mm2/s] vs -0.0027 mm2/s [95% CI, -0.0041 to -0.0014 mm2/s]; P = .07). Among APOE*E4 carriers, the annual DTI-FA decline was significantly lower in the group treated with ω-3 than the placebo group (-0.0016 mm2/s [95% CI, -0.0032 to 0.0020 mm2/s] vs -0.0047 mm2/s [95% CI, -0.0067 to -0.0025 mm2/s]; P = .04). Adverse events were similar between treatment groups.
In this 3-year randomized clinical trial, ω-3 treatment was safe and well-tolerated but failed to reach significant reductions in WML accumulation or neuronal integrity breakdown among all participants, which may be attributable to sample size limitations. However, neuronal integrity breakdown was reduced by ω-3 treatment in APOE*E4 carriers, suggesting that this treatment may be beneficial for this specific group.
ClinicalTrials.gov Identifier: NCT01953705.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>39088212</pmid><doi>10.1001/jamanetworkopen.2024.26872</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Aged, 80 and over Clinical trials Dementia Docosahexaenoic Acids - pharmacology Docosahexaenoic Acids - therapeutic use Eicosapentaenoic Acid - pharmacology Eicosapentaenoic Acid - therapeutic use Fatty Acids, Omega-3 - therapeutic use Female Humans Magnetic Resonance Imaging - methods Male Neurology Older people Online Only Original Investigation Polyunsaturated fatty acids Secondary Prevention - methods White Matter - diagnostic imaging White Matter - drug effects White Matter - pathology |
| title | ω-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial |
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