The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial
•University students aged 18–29 years are at risk of developing affective disorders.•This may have been exacerbated by enforced isolation due to SARS-CoV-2 pandemic.•Pharmacological and cognitive behavioural therapies are not suitable for all.•Omega-3 fatty acid trials in young adults are often negl...
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| Veröffentlicht in: | Prostaglandins, leukotrienes and essential fatty acids leukotrienes and essential fatty acids, 2021-10, Vol.173, p.102335-102335, Article 102335 |
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| container_title | Prostaglandins, leukotrienes and essential fatty acids |
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| creator | Kelaiditis, Christos F. Gibson, E. Leigh Dyall, Simon C. |
| description | •University students aged 18–29 years are at risk of developing affective disorders.•This may have been exacerbated by enforced isolation due to SARS-CoV-2 pandemic.•Pharmacological and cognitive behavioural therapies are not suitable for all.•Omega-3 fatty acid trials in young adults are often neglected by the literature.•This study will explore EPA and supporting nutrients on mood of young adults.
Anxiety disorders affect nearly 20% of young adults aged 18–29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034. |
| doi_str_mv | 10.1016/j.plefa.2021.102335 |
| format | Article |
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Anxiety disorders affect nearly 20% of young adults aged 18–29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.</description><identifier>ISSN: 0952-3278</identifier><identifier>EISSN: 1532-2823</identifier><identifier>DOI: 10.1016/j.plefa.2021.102335</identifier><identifier>PMID: 34461561</identifier><language>eng</language><publisher>Scotland: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Anxiety ; Anxiety - drug therapy ; Depression ; Depression - drug therapy ; Dietary Supplements ; Docosahexaenoic acid ; Docosahexaenoic Acids - therapeutic use ; Double-Blind Method ; Eicosapentaenoic acid ; Eicosapentaenoic Acid - therapeutic use ; Female ; Humans ; Magnesium - therapeutic use ; Male ; Patient Health Questionnaire ; Randomized Controlled Trials as Topic ; Stress ; Stress, Psychological - drug therapy ; Vitamin E - therapeutic use ; Young Adult</subject><ispartof>Prostaglandins, leukotrienes and essential fatty acids, 2021-10, Vol.173, p.102335-102335, Article 102335</ispartof><rights>2021 Elsevier Ltd</rights><rights>Copyright © 2021 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c359t-e97c9253df34b6021a7274e4f3431232b78526b5608fcbf4d840c66f97a3b4e13</citedby><cites>FETCH-LOGICAL-c359t-e97c9253df34b6021a7274e4f3431232b78526b5608fcbf4d840c66f97a3b4e13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.plefa.2021.102335$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34461561$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kelaiditis, Christos F.</creatorcontrib><creatorcontrib>Gibson, E. Leigh</creatorcontrib><creatorcontrib>Dyall, Simon C.</creatorcontrib><title>The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial</title><title>Prostaglandins, leukotrienes and essential fatty acids</title><addtitle>Prostaglandins Leukot Essent Fatty Acids</addtitle><description>•University students aged 18–29 years are at risk of developing affective disorders.•This may have been exacerbated by enforced isolation due to SARS-CoV-2 pandemic.•Pharmacological and cognitive behavioural therapies are not suitable for all.•Omega-3 fatty acid trials in young adults are often neglected by the literature.•This study will explore EPA and supporting nutrients on mood of young adults.
Anxiety disorders affect nearly 20% of young adults aged 18–29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anxiety</subject><subject>Anxiety - drug therapy</subject><subject>Depression</subject><subject>Depression - drug therapy</subject><subject>Dietary Supplements</subject><subject>Docosahexaenoic acid</subject><subject>Docosahexaenoic Acids - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Eicosapentaenoic acid</subject><subject>Eicosapentaenoic Acid - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Magnesium - therapeutic use</subject><subject>Male</subject><subject>Patient Health Questionnaire</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Stress</subject><subject>Stress, Psychological - drug therapy</subject><subject>Vitamin E - therapeutic use</subject><subject>Young Adult</subject><issn>0952-3278</issn><issn>1532-2823</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v1DAQhiMEotvCL0BCPnIgS_yRLyQOVaGAVNgD5Ww59rjrlRMH20Hs_-QHMekWjpw8nnnnmbHfonhBqy2taPPmsJ09WLVlFaOYYZzXj4oNrTkrWcf442JT9TUrOWu7s-I8pUNVoZKKp8UZF6KhdUM3xe_bPRCwFnROJFiiyN7d7Qk4HZKaYcoKpuA0UdoZMi4-u2nJ0WGBpGXGBcY1DBMZQaUlwj0kZQzSa6KmXw7yEU9DDMxr0qHUTeQYlumOKIPA9JZ8y4s5kjmGHHTwxIZIvq5Tvux275FCIgLC6BIgJiyDh3LwDpmzVxqGUOow5Ri8xzp2Kf-seGKVT_D84bwovl9_uL36VN7sPn6-urwpNa_7XELf6p7V3Fguhgb_RrWsFSDwyinjbGi7mjVD3VSd1YMVphOVbhrbt4oPAii_KF6duLj6jwVSlrikBu_VBGFJktVN23dUtD1K-UmqY0gpgpVzdKOKR0krudopD_LeTrnaKU92YtfLhwHLMIL51_PXPxS8OwkAn_nTQZRJozkajItoqTTB_XfAH-CctoQ</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Kelaiditis, Christos F.</creator><creator>Gibson, E. Leigh</creator><creator>Dyall, Simon C.</creator><general>Elsevier Ltd</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>7X8</scope></search><sort><creationdate>202110</creationdate><title>The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial</title><author>Kelaiditis, Christos F. ; Gibson, E. 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Leigh</creatorcontrib><creatorcontrib>Dyall, Simon C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Prostaglandins, leukotrienes and essential fatty acids</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kelaiditis, Christos F.</au><au>Gibson, E. Leigh</au><au>Dyall, Simon C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial</atitle><jtitle>Prostaglandins, leukotrienes and essential fatty acids</jtitle><addtitle>Prostaglandins Leukot Essent Fatty Acids</addtitle><date>2021-10</date><risdate>2021</risdate><volume>173</volume><spage>102335</spage><epage>102335</epage><pages>102335-102335</pages><artnum>102335</artnum><issn>0952-3278</issn><eissn>1532-2823</eissn><abstract>•University students aged 18–29 years are at risk of developing affective disorders.•This may have been exacerbated by enforced isolation due to SARS-CoV-2 pandemic.•Pharmacological and cognitive behavioural therapies are not suitable for all.•Omega-3 fatty acid trials in young adults are often neglected by the literature.•This study will explore EPA and supporting nutrients on mood of young adults.
Anxiety disorders affect nearly 20% of young adults aged 18–29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.</abstract><cop>Scotland</cop><pub>Elsevier Ltd</pub><pmid>34461561</pmid><doi>10.1016/j.plefa.2021.102335</doi><tpages>1</tpages></addata></record> |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Adolescent Adult Anxiety Anxiety - drug therapy Depression Depression - drug therapy Dietary Supplements Docosahexaenoic acid Docosahexaenoic Acids - therapeutic use Double-Blind Method Eicosapentaenoic acid Eicosapentaenoic Acid - therapeutic use Female Humans Magnesium - therapeutic use Male Patient Health Questionnaire Randomized Controlled Trials as Topic Stress Stress, Psychological - drug therapy Vitamin E - therapeutic use Young Adult |
| title | The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial |
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