Water Intake and Glycemic Response : Preliminary Study

Healthy Clinical Trial

Official title:

Water Intake and Glycemic Response : Preliminary Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02625363
• Other study ID #: Nutrifood
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2015
• Last updated: December 4, 2015
• Start date: November 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Nutrifood Research Center, Jakarta, Indonesia
• Contact: Vanessa Yolanda, SSi
• Email: vanessa.yolanda[@]nutrifood.co.id
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial Summary

Glycemic index concept is widely used to determine impact of a food to blood glucose. Several studies showed that water content and intake after meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. Currently these studies found conflicting results. Therefore, this study aims to determine whether water intake, specifically after meal, may influence the glycemic response and glycemic index value of the meal.

Description:

Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Glucose Ref - Std
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'
• Glucose Ref and 450 ml water
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
• White Bread with 250 ml water
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'
• White Bread and 700 ml water
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'
• 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 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'

Locations

Country	Name	City	State
Indonesia	PT Nutrifood Indonesia	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Nutrifood Research Center, Jakarta, Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 h postprandial blood glucose level (Glycemic Response)		fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min	No
Primary	Glycemic index value of meal (white bread)	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	No