健康な若年成人の心血管疾患リスクに対する SREBF1 多型と卵黄:無作為化、2 期間、単盲検、クロスオーバー試験
Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to confirm and extend this finding by characterizing the effects of cholesterol from egg yolks on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1 C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg yolks.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Shandong
-
Jinan、Shandong、中国、250012
- Shandong University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- SREBF1 C/G/G minor allele carriers and AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119, age 18-25 years, body mass index (BMI) 18~23.9 kg/m2 , blood pressure within normal ranges (Systolic blood pressure < 140mmHg, diastolic blood pressure < 90mmHg), lipid profiles within normal ranges according to test kit instructions (fasting serum triglycerides < 1.7mmol/L, fasting serum total cholesterol < 5.2 mmol/L, fasting serum low density lipoprotein cholesterol (LDL-C) < 3.12 mmol/L, fasting serum high density lipoprotein cholesterol (HDL-C) >1.04 mmol/L ), liver and kidney functions within normal ranges according to test kit instructions (alanine aminotransferase (ALT) 9~50 U/L for male, 7~40 U/L for female; aspartate transaminase (AST) 15~40 U/L for male, 13~35 U/L for female; creatinine 62~115 μmol/L for male, 53~97 μmol/L for female; blood urea nitrogen (BUN), 1.43~7.14 mmol/L), both parents are Chinese Han nationality, willing to eat two or more eggs, and willing to maintain "Three Low Diet" except when they were given egg yolks during the study.
Exclusion Criteria:
- History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.
研究計画
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: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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Group A
Group A was consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. And it was first assigned egg yolk intervention during intervention period 1, and then macronutrient equivalent control during intervention period 2 |
Two egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights. The macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk. |
|
他の:Group B
Group B was also consisted of 16 rs2236513/rs2297508/rs4925119 C/G/G carriers and 16 AA/CC/AA homozygotes. It was first assigned macronutrient equivalent control during intervention period 1, and then egg yolk during intervention period 2 |
Two egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights. The macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk. |
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 |
|---|---|---|
|
Changes in serum lipids
時間枠:Week 0, week 4, week 8, week 16
|
Serum lipids including serum total cholesterol, LDL-C, HDL-C and LDL-C/HDL-C, triglycerides |
Week 0, week 4, week 8, week 16
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Serum Cholesterol-Related Metabolites Measured by Targeted Analytical Assays and PBMC ABCA1 mRNA Expression Measured by RT-qPCR
時間枠:At the beginning and end of each 4-week intervention period during the 16-week trial.
|
Serum metabolites-Description Serum corticosteroid and bile acid concentrations were measured using targeted analytical assays. Changes were calculated as concentrations at the end minus those at the beginning of each intervention period. PBMC ABCA1 mRNA-Description PBMC ABCA1 mRNA expression was measured by RT-qPCR and expressed using the ΔΔCt method. Changes were assessed from the beginning to the end of each intervention period. |
At the beginning and end of each 4-week intervention period during the 16-week trial.
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Shixiu Zhang, Ph. D.、Shandong University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CNS-W2018A44
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?
IPD プランの説明
All IPD that underlie results in a publication.
IPD 共有時間枠
All IPD that underlie results in a publication will be shared as claimed by the journal that the publication is published.
IPD 共有アクセス基準
Can access data by contacting Shixiu Zhang.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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