- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02625363
Water Intake and Glycemic Response : Preliminary Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 13920
- Rekruttering
- PT Nutrifood Indonesia
-
Ta kontakt med:
- Astri Kurniati, MAppSc
- E-post: astri@nutrifood.co.id
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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'
|
Eksperimentell: 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
|
Eksperimentell: 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'
|
Eksperimentell: 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' |
Eksperimentell: 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' |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
2 h postprandial blood glucose level (Glycemic Response)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Vanessa Yolanda, Ssi, Nutrifood Research Center
- Studiestol: Astri Kurniati, MAppSc, Nutrifood Research Center
- Hovedetterforsker: Lina Antono, MSc, Nutrifood Research Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Nutrifood
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