Intervention With Omega Fatty Acids in High-risk Patients
2016年12月19日 更新者：Haukeland University Hospital
Intervention With Omega Fatty Acids in High-risk Patients With Hypertriglyceridemic Waist
In order to reduce cardiovascular risk, current European guidelines recommend a diet low on saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).
Polyunsaturated fatty acids can be classified into omega-3 and omega-6.
However the results from recent meta-analyses investigating coronary risk outcomes did not clearly support a low intake of saturated fatty acids and a high intake of omega-3 or omega-6.
The aim of this study is to investigate the short term effects of a high intake of PUFAs on microvascular function, lipids, inflammation and other cardiovascular risk factors in inactive patients with increased waistline.
調査の概要
研究の種類
介入
入学 (実際)
40
段階
- フェーズ2
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- Physical inactivity (< 2 h vigorous/active exercise training per week)
Exclusion Criteria:
- Regular use of certain prescription medications at baseline
- Severe psychiatric illness
- Pregnancy
- Pacemaker or implantable cardioverter defibrillator
- Cigarette smoking
- Previous coronary intervention
- Concomitant use of dietary supplements
- Use of omega-3 supplements at baseline
- Alcohol or drug abuse or any condition associated with poor compliance.
- Scheduled hospitalisation during the course of the study.
- Participation in a clinical trial in the last 12 weeks, or prior randomisation.
- Blood donation within the preceding 12 weeks.
- Diabetes Mellitus Type 1 or type 2
- Triglycerides > 5 mmol/l
- Previous bariatric surgery
- Malabsorption disorder
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Omega-3 fatty acid
Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
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Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively.
The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
他の名前：
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実験的：Omega-6 fatty acid
Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
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Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively.
The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in lipid profile
時間枠：Measured at baseline and after 8 weeks
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High-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol and triglycerides (TG) will be measured in plasma/serum (mmol/L).
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Measured at baseline and after 8 weeks
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Changes in particle concentrations of lipoproteins of different sizes
時間枠：Measured at baseline and week 8
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Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.
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Measured at baseline and week 8
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Changes in lipoprotein particle sizes
時間枠：Measured at baseline and week 8
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Lipoprotein particle size (nm) analysis will be performed by proton nuclear magnetic resonance (NMR) spectroscopy.
The size will be derived from the sum of diameter of each subclass multiplied by its relative mass percentage based on its methyl NMR signal.
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Measured at baseline and week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in body composition
時間枠：Measured at baseline and week 8
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Body composition will be measured by bioelectrical impedance (InBody 720).
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Measured at baseline and week 8
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Changes in body weight
時間枠：Measured at baseline and week 8
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Measured at baseline and week 8
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Changes in waist and hip circumference
時間枠：Measured at baseline and week 8
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Measured at baseline and week 8
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Changes in circulating markers of inflammation, also including adipokines and kynurenine
時間枠：Measured at baseline and week 8
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Inflammatory markers and adipokines will be measured in serum/plasma, e.g tumor necrosis factor-α (TNF-α), interleukins, macrophage inflammatory protein 1-α (MIP-1-α) and granulocyte-macrophage colony stimulating factor (GM-CSF).
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Measured at baseline and week 8
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Changes in markers of inflammation in adipose tissue
時間枠：Measured at baseline and week 8
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Inflammatory markers like TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).
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Measured at baseline and week 8
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Changes in one carbon metabolites
時間枠：Measured at baseline and week 8
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Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.
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Measured at baseline and week 8
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Changes in microbiota
時間枠：Measured at baseline and week 8
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Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).
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Measured at baseline and week 8
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Changes in endothelial function
時間枠：Measured at baseline and week 8
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Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.
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Measured at baseline and week 8
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Changes in carnitine and metabolites
時間枠：Measured at baseline and week 8
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Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.
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Measured at baseline and week 8
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Changes in gene expression in adipose tissue
時間枠：Measured at baseline and week 8
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Gene expression in adipose tissue will be measured by microarray and quantitative PCR.
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Measured at baseline and week 8
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Changes in amino acids
時間枠：Measured at baseline and week 8
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Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.
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Measured at baseline and week 8
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Changes in gene expression i whole blood
時間枠：Measured at baseline and week 8
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Gene expression in full blood will be measured by quantitative PCR.
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Measured at baseline and week 8
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Changes in apolipoproteins
時間枠：Measured at baseline and week 8
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Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.
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Measured at baseline and week 8
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Espen Rostrup, MD PhD、Haukeland University Hospital, Department of Heart Disease
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年3月1日
一次修了 (実際)
2016年4月1日
研究の完了 (実際)
2016年4月1日
試験登録日
最初に提出
2015年9月9日
QC基準を満たした最初の提出物
2016年1月4日
最初の投稿 (見積もり)
2016年1月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月20日
QC基準を満たした最後の更新が送信されました
2016年12月19日
最終確認日
2016年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2014/2336
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