Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
2022年6月29日 更新者：Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
17
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。
研究場所
-
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Lund、スウェーデン
- Aventure AB
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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
35年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
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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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プラセボコンパレーター：Reference
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This intervention is based on white rice.
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アクティブコンパレータ：Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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アクティブコンパレータ：Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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アクティブコンパレータ：Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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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 |
|---|---|---|
|
Postprandial capillary blood glucose iAUC (0-120 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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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 |
|---|---|---|
|
Postprandial capillary blood glucose Cmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose Tmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Fasting capillary blood glucose
時間枠：Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
|
Postprandial capillary blood glucose iAUC (0-60 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial Insulin iAUC(0-120 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial Insulin Cmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial Insulin Tmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Fasting Insulin
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial insulin iAUC (0-60 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fasting GLP-1
時間枠：Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
|
GLP-1 iAUC(0-120 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 iAUC(0-60 min)
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Cmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Tmax
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Fasting PYY
時間枠：Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting PYY the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
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PYY 2-hour mean concentration
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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PYY 1-hour mean concentration
時間枠：Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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
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 (実際)
2022年3月17日
一次修了 (実際)
2022年6月13日
研究の完了 (実際)
2022年6月13日
試験登録日
最初に提出
2022年3月14日
QC基準を満たした最初の提出物
2022年3月14日
最初の投稿 (実際)
2022年3月23日
学習記録の更新
投稿された最後の更新 (実際)
2022年7月5日
QC基準を満たした最後の更新が送信されました
2022年6月29日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TSP2201
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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