Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 (ILIAS-2)
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
調査の概要
詳細な説明
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
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
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Brandenburg
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Bergholz-Rehbrücke、Brandenburg、ドイツ、14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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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:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
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：他の
- 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：4倍
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：Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
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|
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アクティブコンパレータ：Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
|
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 |
|---|---|---|
|
change in release of GIP
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose release of GIP between the two interventions
|
4 weeks (cross-over)
|
|
change in release of GLP-1
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-1 between the two interventions
|
4 weeks (cross-over)
|
|
change in release of GLP-2
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-2 between the two interventions
|
4 weeks (cross-over)
|
|
change in release of PYY
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose release of PYY between the two interventions
|
4 weeks (cross-over)
|
|
change in release of insulin
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose release of insulin between the two interventions
|
4 weeks (cross-over)
|
|
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose insulin secretion between the two interventions
|
4 weeks (cross-over)
|
|
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
時間枠：4 weeks (cross-over)
|
change in fasting state and post-glucose insulin sensitivity between the two interventions
|
4 weeks (cross-over)
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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 (見積もり)
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。