- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625363
Water Intake and Glycemic Response : Preliminary Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 13920
- Recruiting
- PT Nutrifood Indonesia
-
Contact:
- Astri Kurniati, MAppSc
- Email: astri@nutrifood.co.id
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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'
|
|
Experimental: 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
|
|
Experimental: 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'
|
|
Experimental: 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' |
|
Experimental: 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' |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2 h postprandial blood glucose level (Glycemic Response)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vanessa Yolanda, Ssi, Nutrifood Research Center
- Study Chair: Astri Kurniati, MAppSc, Nutrifood Research Center
- Principal Investigator: Lina Antono, MSc, Nutrifood Research Center
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nutrifood
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