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Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

2026年9月17日 更新者：National Heart, Lung, and Blood Institute (NHLBI)

Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia

Background:

Obesity is known to lead to diseases such as diabetes and high cholesterol (or fats) in the blood (hyperlipidemia). But no one knows why. Researchers think that high levels of fat in the blood may block important nutrients, such as vitamin E, from reaching places they are needed in the body.

Objective:

To learn how high-fat meals affect levels of vitamin E in the blood.

Eligibility:

People aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.

Design:

Participants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.

Participants will be screened. They will have a physical exam and blood tests.

After this visit, all participants must stop taking any dietary supplements.

Those who use them must also stop taking any drugs to lower their blood sugar and blood fats. These participants will have an extra visit for blood tests after 60 days.

The next visit will include 2 imaging scans:

Magnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.

Dual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.

On day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.

On day 2, they will drink high-fat shakes at 8 am, noon, and 4 pm. They will have blood draws every hour for 17 hours, and then every 2 hours until 7 am. The blood will be taken from a tube inserted into a vein and left in place for the day.

On day 3, they will go home.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Study Description:

A controlled interventional study of effects of postprandial hypertriglyceridemia from three consecutive high-fat vitamin E-stripped meals on the dynamics of plasma vitamin E concentrations in subjects with baseline normo- and hyperlipidemia, to explore the concept of vitamin E sequestration by fats in plasma.

Objectives:

Primary Objective: Compare effects of postprandial hypertriglyceridemia (PHTG) on plasma/lipoprotein vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.

Secondary Objectives: Compare effects of postprandial hypertriglyceridemia (PHTG) on other fat-soluble vitamins (gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A]) and related vitamers (beta-carotene, lycopene lutein/zeaxanthin) between subjects with baseline normo- and hyperlipidemia.

Tertiary/Exploratory Objectives:

  1. Compare effects of individual high-fat meals on the dynamics of vitamin E, gamma-tocopherol, phylloquinone [K1], menaquinone [K2], 25-OH vitamin D, retinol [A], and other carotenoids between subjects with baseline normo- and hyperlipidemia.
  2. Compare effects of postprandial hypertriglyceridemia (PHTG) and resultant vitamin E dynamics on: red blood cell (RBC) membrane deformability, fluidity, and oxygen exchange capacity (p50); RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid; fasting glucose and insulin; oxidized LDL, coenzyme Q10, and plasma adipokine profile between subjects with baseline normo- and hyperlipidemia;
  3. Explore effects of postprandial hypertriglyceridemia on small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. Explore the influence of genetic variance on the metabolism of vitamin E and other fat-soluble vitamins and related vitamers in subjects with baseline normo- and hyperlipidemia.

Endpoints:

Primary Endpoint: AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23, by cohort.

Secondary Endpoints: AUC of gamma-tocopherol, phylloquinone [K1], menaquinone [K2], 25-OH vitamin D and retinol [A] from hour 1 to hour 23, by cohort.

Tertiary/Exploratory Endpoints:

  1. Between the timepoints that reflect consuming 3 high-fat meals, AUC of vitamin E, gamma-tocopherol, phylloquinone [K1], menaquinone [K2], 25-OH vitamin D, retinol [A], and other carotenoids will be separately calculated for each participant.
  2. Over the course of inpatient visit, RBC membrane deformability/fluidity, p50, RBC vitamin E, plasma vitamin C, plasma dehydroascorbic acid, blood glucose, insulin, c-peptide, oxidized LDL, coenzyme Q10 and serum adipokine profiles in each subject.
  3. Over the course of inpatient visit, small RNAs including microRNAs, tRNAs, and PIWI-interacting RNAs.
  4. Genetic variance (single nucleotide polymorphisms, SNPs)- dependent change in lipid-soluble vitamin dynamics over the course of inpatient visit in each subject.

研究の種類

介入

入学 (推定)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Robert D Shamburek, M.D.
  • 電話番号：(301) 496-3460
  • メール：bobs@mail.nih.gov

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • National Institutes of Health Clinical Center
        • コンタクト：
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • 電話番号：TTY dial 711 (800) 411-1222
          • メール：ccopr@nih.gov
        • コンタクト：

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

  • INCLUSION CRITERIA

Cohort 1

  1. Males and females between the ages of 18 to 65
  2. BMI 18.5 - 26.9 kg/m^2
  3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
  4. Normotensive, not on medications for hypertension
  5. Not on glucose-lowering or lipid-lowing medications
  6. Screening labs with baseline HbA1c <5.7%, baseline fasting triglyceride < 150 mg/dL and LDL <100 mg/dL
  7. Liver fat <2%

Cohort 2

  1. Males and females between the ages of 18 to 65
  2. BMI >26 kg/m^2 and <36 kg/m^2
  3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.
  4. Screening labs with baseline HbA1c <= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride < 500 mg/dL and LDL <190 mg/dL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.
  5. Liver fat <2%

EXCLUSION CRITERIA

  1. For women: pregnancy or currently breastfeeding
  2. Subjects <18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects.
  3. Subjects >65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals.
  4. Heavy alcohol user (males with >2 drinks per day or >14 drinks per week; female with >1 drinks per day or >7 drinks per week)
  5. Current smoker, or former smoker who quit smoking <15 years ago
  6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months
  7. Subjects with lactose intolerance unwilling to take lactase
  8. Subjects with type 1 diabetes
  9. Subjects with hemoglobin <11 g/dL or hematocrit <33%
  10. Subjects with abnormal liver function test results
  11. Subjects with liver fat >= 2% on abdominal MRI
  12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases
  13. Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism
  14. Subjects on glucocorticoids >1 week (not including topical glucocorticoids)
  15. Subjects with HIV
  16. Subjects with uncontrolled psychiatric and/or behavioral disorders
  17. Subjects taking diabetes medications other than metformin
  18. Anticipated surgery during the study period
  19. Subjects with severe medication-resistant claustrophobia
  20. Subjects who are unwilling to stop medications, vitamins and/or dietary supplements that investigators have requested to be held
  21. Subjects participating in any other clinical study without informing investigators
  22. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a participant or staff member

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：基礎科学
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Healthy subjects
Three consecutive high-fat vitamin E-stripped meals
ダイエットサプリメント：High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals
実験的：Subjects with hyperlipidemia
Three consecutive high-fat vitamin E-stripped meals
ダイエットサプリメント：High fat liquid shake
Three consecutive high-fat vitamin E-stripped meals

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
AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.
時間枠：From hour 1 to hour 23
Compare the effects of postprandial hypertriglyceridemia on plasma vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.
From hour 1 to hour 23

二次結果の測定

結果測定
メジャーの説明
時間枠
AUC of gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A] from hour 1 to hour 23 by cohort.
時間枠：From hour 1 to hour 23
Compare the effects of postprandial hypertriglyceridemia on other fat-soluble vitamins (gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A]) and related vitamers (beta-carotene, lycopene lutein/zeaxanthin) in subjects between baseline normo- and hyperlipidemia.
From hour 1 to hour 23

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。

スポンサー

National Heart, Lung, and Blood Institute (NHLBI)

捜査官

  • 主任研究者：Robert D Shamburek, M.D.、National Heart, Lung, and Blood Institute (NHLBI)

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。

一般刊行物

便利なリンク

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 (推定)

2026年9月23日

一次修了 (推定)

2028年11月30日

研究の完了 (推定)

2029年3月31日

試験登録日

最初に提出

2026年7月18日

QC基準を満たした最初の提出物

2026年7月18日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年7月21日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 10002623
  • 002623-H

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data underlying results reported in publications may be shared. Depending on the sensitivity of the dataset and risk of re-identification, data may be made available through either an open-access repository or a controlled-access repository, consistent with informed consent, institutional review, and applicable policies.@@@@@@

IPD 共有時間枠

Beginning following de-identification and publication of the primary results, or other prespecified time point, and continuing for as long as the repository or access mechanism remains available.

IPD 共有アクセス基準

Access to de-identified individual participant data will be determined based on the sensitivity of the data and disclosure risk. Data appropriate for broad sharing may be deposited in an open-access repository. Data requiring additional protections may be made available through a controlled-access mechanism subject to review and any applicable agreements.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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