Glycemic Index of Commonly Consumed Sweeteners
調査の概要
詳細な説明
This three arm study is intended to add to scientific knowledge by providing accurate assessments of the glycemic index commonly consumed food items. This will be used in the scientific literature to assess the glycemic index of foods containing various sweeteners. Participants will be monitored for a total of 10 weeks.
The glycemic index is defined as the "incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed." In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.
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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Connecticut
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New Haven、Connecticut、アメリカ、06511
- Yale Center for Clinical Investigation Church Street Research Unit
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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:
- BMI 18.5-24.9 (lean)
- no medications
- no weight changes over the previous 6 months (defined as >=10% change in body weight)
Exclusion Criteria:
- current active participation in a weight loss program (dietary or physical activity focused)
- prior bariatric surgery
- significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes
- women who are pregnant or lactating
- medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
- no major medical or surgical event requiring hospitalization in the past 3 months
- no disease or drugs that influence digestion
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Glucose100
Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.
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For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes.
Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink.
Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
他の名前：
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アクティブコンパレータ：Glucose50
Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.
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For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes.
Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink.
Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
他の名前：
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アクティブコンパレータ：Glucose42
Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.
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For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes.
Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink.
Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
他の名前：
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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 |
|---|---|---|
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Mean Glycemic Index
時間枠：2 hours
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The mean glycemic index of participants will be calculated by averaging the 3 calculated glycemic index values for each of the 3 types of sweetener. Each participant will be randomly given 1 of 3 the commonly consumed sweeteners three different times over a nine week period- for a total of 3 observations per arm. Glycemic index is measured by giving test subjects the commonly consumed sweetener, and then measuring blood glucose response over a two hour time period using an Oral Glucose Tolerance Test. That response is then compared against a reference (glucose) and averaged across all subjects to get a relative index value. The glycemic index (GI) is a ranking of carbohydrates on a scale from 0 to 100 according to the extent to which they raise blood sugar levels after eating. (http://www.glycemicindex.com/about.php) |
2 hours
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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 |
|---|---|---|
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Body Mass Index (BMI)
時間枠：Baseline
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BMI will be captured at the baseline visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters)
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Baseline
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Body Mass Index (BMI)
時間枠：9 weeks
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BMI will be captured at the 9 weeks visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters)
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9 weeks
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Percent Fat Mass
時間枠：Baseline
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Percent fat mass at baseline will be captured using the Tanita Body Fat Analyzer.
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Baseline
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Percent Fat Mass
時間枠：9 weeks
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Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.
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9 weeks
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Total Fat Mass
時間枠：Baseline
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Total fat mass at baseline will be captured using the Tanita Body Fat Analyzer.
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Baseline
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Total Fat Mass
時間枠：9 weeks
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Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.
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9 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Eugene Shapiro, MD、Yale School of Medicine
- 主任研究者：Ania M Jastreboff, MD, PhD、Yale School of Medicine
- 主任研究者：Robert S Sherwin, MD、Yale School of Medicine
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
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。