Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
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
-
-
-
Seoul、大韓民国、07327
- ICAN Nutrition Education and Research
-
-
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: at least three out of five metabolic syndrome components
- waist circumference (WC) >90 cm for men and >80 cm for women
- hypertension (DBP ≥85 and <110 mm Hg)
- hyperglycemia (≥100 mg/dL)
- elevated plasma TG concentrations (≥150 mg/dL)
- decreased plasma HDL-C concentrations (<40 mg/dL for men and <50 mg/dL for women)
Exclusion Criteria:
- the presence of morbid obesity (BMI ≥40)
- the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- a medical history of hypocaloric diet consumption within the past year
- gastrointestinal tract disorders
- post-menopausal women
- smokers
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：処理
- 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Walnut-Control
|
45 g of walnut / iso-caloric white bread
|
|
実験的：Control-Walnut
|
45 g of walnut / iso-caloric white bread
|
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 of waist circumference
時間枠：after 16 weeks of daily walnut consumption
|
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood triglyceride level
時間枠：after 16 weeks of daily walnut consumption
|
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood high-density lipoprotein cholesterol levels
時間枠：after 16 weeks of daily walnut consumption
|
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood pressure
時間枠：after 16 weeks of daily walnut consumption
|
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood glucose level
時間枠：after 16 weeks of daily walnut consumption
|
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
|
after 16 weeks of daily walnut consumption
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
changes of total cholesterol level
時間枠：after 16 weeks of daily walnut consumption
|
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum apolipoprotein B level
時間枠：after 16 weeks of daily walnut consumption
|
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum adiponectin level
時間枠：after 16 weeks of daily walnut consumption
|
Blood adiponectin (ug/mL) levels were measured using ELISA.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum leptin level
時間枠：after 16 weeks of daily walnut consumption
|
Blood leptin (ug/mL) levels were measured using ELISA.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum insulin level
時間枠：after 16 weeks of daily walnut consumption
|
Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
|
after 16 weeks of daily walnut consumption
|
|
changes of low-density lipoprotein cholesterol level
時間枠：after 16 weeks of daily walnut consumption
|
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
協力者と研究者
出版物と役立つリンク
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
メタボリック・シンドロームの臨床試験
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... と他の協力者募集ミトコンドリア病 | 網膜色素変性症 | 重症筋無力症 | 好酸球性胃腸炎 | もやもや病 | 多系統萎縮症 | 平滑筋肉腫 | 白質ジストロフィー | 痔瘻 | 脊髄小脳失調症3型 | フリードライヒ失調症 | ケネディ病 | ライム病 | 血球貪食性リンパ組織球症 | 脊髄小脳失調症1型 | 脊髄小脳性運動失調2型 | 脊髄小脳失調症6型 | ウィリアムズ症候群 | ヒルシュスプルング病 | 糖原病 | 川崎病 | 短腸症候群 | 低ホスファターゼ症 | レーバー先天性黒内障 | 口臭 | アカラシア心臓 | 多発性内分泌腫瘍 | リー症候群 | アジソン病 | 多発性内分泌腫瘍2型 | 強皮症 | 多発性内分泌腫瘍1型 | 多発性内分泌腫瘍2A型 | 多発性内分泌腫瘍2B型 | 非定型溶血性尿毒症症候群 | 胆道閉鎖症 | 痙性運動失調 | WAGR症候群 | アニリディア | 一過性全健忘症 | 馬尾症候... およびその他の条件アメリカ, オーストラリア
foodの臨床試験
-
Montefiore Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了
-
Alliance for International Medical ActionInstitut National de la Santé Et de la Recherche Médicale, France; Institut de Recherche en... と他の協力者完了
-
Centre Georges Francois Leclerc積極的、募集していないステージ IV の非小細胞気管支肺癌であり、現在のフランスの推奨に従って第一選択治療の恩恵を受けるフランス
-
NYU Langone HealthNational Institute on Minority Health and Health Disparities (NIMHD)募集
-
South Dakota State UniversityUniversity of Missouri-Columbia; Ohio State University; Michigan State University; Purdue University と他の協力者完了食料安全保障 | 栄養価
-
University of California, Los AngelesAga Khan Universityまだ募集していません栄養失調、子供 | 小児期の重度の急性栄養失調 | 神経認知、子供パキスタン
-
SEAMEO Regional Centre for Food and NutritionDirektorat Riset dan Pengabdian Masyarakat Universitas Indonesia; University of Brawijaya完了栄養性貧血 | 栄養不足 | 栄養失調 | 栄養遺伝学 | ニュートリゲノミクス | 線形計画 | 食品ベースの推奨事項インドネシア
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.募集