- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02625363
Water Intake and Glycemic Response : Preliminary Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesien, 13920
- Rekrytering
- PT Nutrifood Indonesia
-
Kontakt:
- Astri Kurniati, MAppSc
- E-post: astri@nutrifood.co.id
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Glucose Ref - Std
250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference
|
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'
|
Experimentell: 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
|
Experimentell: 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'
|
Experimentell: 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' |
Experimentell: 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' |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
2 h postprandial blood glucose level (Glycemic Response)
Tidsram: 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
|
|
Glycemic index value of meal (white bread)
Tidsram: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
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.
|
fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Vanessa Yolanda, Ssi, Nutrifood Research Center
- Studiestol: Astri Kurniati, MAppSc, Nutrifood Research Center
- Huvudutredare: Lina Antono, MSc, Nutrifood Research Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Nutrifood
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