Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.
In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.
調査の概要
詳細な説明
After enrollment, participants will be asked to come to the investigational site 6 times for:
- two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
- 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.
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
-
-
-
Lausanne、スイス、1000
- Nestlé Research Center
-
-
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 between 18.5 and 29.9 kg/m2
- Fasting capillary blood glucose level ≤ 7 mmol/L
- Able to understand and sign an informed consent form
Exclusion Criteria:
- Pregnancy on anamnesis
- Lactating mothers
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
- Family history of type 2 diabetes (parents)
- Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor)
- Known ageusia or other tasting trouble
- Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics)
- Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor
- Major medical/surgical event requiring hospitalisation in the last 3 months
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
プラセボコンパレーター:Product 1
Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
|
アクティブコンパレータ:Product 2
Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
|
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 4
|
アクティブコンパレータ:Product 3
Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 4
|
アクティブコンパレータ:Product 4
Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 2, 3, and 4
|
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 |
---|---|---|
Incremental Area under the Curve (iAUC) of plasma glucose
時間枠:0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incremental Area under the Curve (iAUC) of plasma insulin
時間枠:0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
Cmax of plasma glucose
時間枠:between 0 and 3 hours post product intake
|
Maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
Cmax of plasma insulin
時間枠:between 0 and 3 hours post product intake
|
Maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
Tmax of plasma glucose
時間枠:between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
Tmax of plasma insulin
時間枠:between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
Sensory tasting capacity
時間枠:immediately after product intake
|
Assessment of the sweetness of two beverages versus control through a questionnaire
|
immediately after product intake
|
協力者と研究者
捜査官
- 主任研究者:Maurice Beaumont, MD、Société des Produits Nestlé (SPN)
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
- 17.19.BIO
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
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。
Product 2の臨床試験
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.募集
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.募集
-
Pennington Biomedical Research CenterSamsung完了
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics Corporation完了