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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02625350
Other study ID # GI-noodle
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 1, 2015
Last updated December 4, 2015
Start date December 2015
Est. completion date December 2015

Study information

Verified date December 2015
Source Nutrifood Research Center, Jakarta, Indonesia
Contact n/a
Is FDA regulated No
Health authority Indonesia: Departement Kesehatan (Department of Health)
Study type Interventional

Clinical Trial Summary

Glycemic index is commonly used as a method to determine the effect of a food to blood glucose. Despite its carbohydrate and fat content, instant noodle is very popular in Asia, including Indonesia. Based on the serving method, there are instant noodle without and with soup. Studies have shown that water content of a meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. However none specifically studied instant noodles nor the additional water content as soup (not incorporated in the food matrix). Therefore, this study aims to determine whether the serving method of instant noodle (with and without soup) 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 Enrolling by invitation
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: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Instant noodle without soup
First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle without soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
Instant noodle with soup
First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle with soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
Glucose reference
First, fasting blood glucose was measured. Then, subjects consumed the glucose reference and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nutrifood Research Center, Jakarta, 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 Changes in 2-h postprandial blood glucose level blood glucose level will be measured in several time points (12-h fasting, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, and 120 min after sample consumption) through study completion, an average of 1 month No
Secondary Incremental area under the curve (IAUC) of postprandial blood glucose level through study completion, an average of 1 month No
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