- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02625363
Water Intake and Glycemic Response : Preliminary Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 13920
- Reclutamento
- PT Nutrifood Indonesia
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Contatto:
- Astri Kurniati, MAppSc
- Email: astri@nutrifood.co.id
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age between 20-40 years
- fasting blood glucose 70-99 mg/dL
- Indonesians
Exclusion Criteria:
- having diabetes
- smoking
- if women, pregnant or lactating
- being allergic to food used in this study
- having gastrointestinal disturbance
- in regular medication
- refusal to sign the consent form
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Glucose Ref - Std
250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference
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First, fasting blood glucose was measured.
Then, subjects consumed the glucose sample in 5-10 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
|
|
Sperimentale: Glucose Ref and 450 ml water
250 ml glucose solution with 50 gram available carbohydrate per serving.
Sample was consumed with additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption
|
First, fasting blood glucose was measured.
Then, subjects consumed the glucose sample in 5-10 minutes.
Subjects given additional 150 ml water at 45, 75, and 105 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120
|
|
Sperimentale: White Bread with 250 ml water
White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption
|
First, fasting blood glucose was measured.
Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
|
|
Sperimentale: White Bread and 700 ml water
White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption.
Moreover, subjects given additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption
|
Sample consumed with 250 ml water immediately after meal consumption, and additional 150 ml water at 45, 75, and 105 minutes. First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120' |
|
Sperimentale: White Bread with 125 ml water (twice)
Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes
|
Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120' |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
2 h postprandial blood glucose level (Glycemic Response)
Lasso di tempo: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
|
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Glycemic index value of meal (white bread)
Lasso di tempo: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
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The glycemic index is a calculated from measurements of area under the glucose curve after the food is eaten, divided by the corresponding area after the control food is eaten.
The value is multiplied by 100 to represent a percentage of the reference food.
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fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Vanessa Yolanda, Ssi, Nutrifood Research Center
- Cattedra di studio: Astri Kurniati, MAppSc, Nutrifood Research Center
- Investigatore principale: Lina Antono, MSc, Nutrifood Research Center
Pubblicazioni e link utili
Pubblicazioni generali
- Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
- Young KWH, Wolever TMS. Effect of volume and type of beverage consumed with a standard test meal on postprandial blood glucose responses. Nutrition Research 18(11): 1857-1863, 1998
- Torsdottir I, Andersson H. Effect on the postprandial glycaemic level of the addition of water to a meal ingested by healthy subjects and type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1989 Apr;32(4):231-5. doi: 10.1007/BF00285289.
- Gregersen S, Rasmussen O, Winther E, Hermansen K. Water volume and consumption time: influence on the glycemic and insulinemic responses in non-insulin-dependent diabetic subjects. Am J Clin Nutr. 1990 Sep;52(3):515-8. doi: 10.1093/ajcn/52.3.515.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Nutrifood
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