Glycemic Index of Instant Noodle With and Without Soup: Does Serving Method Have an Effect?

Study Overview
=================
Brief 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.

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

Official Title
-----------------
Glycemic Index of Instant Noodle With and Without Soup: Does Serving Method Have an Effect?

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Instant noodle without soup
* Other: Instant noodle with soup
* Other: Glucose reference


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instant noodle without soup<br>Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes and drained | Other: Instant noodle without soup<br>* 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'<br>|
| Experimental: Instant noodle with soup<br>Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes, drained, and given additional 250 ml of water as soup | Other: Instant noodle with soup<br>* 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'<br>|
| Experimental: Glucose reference<br>250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference | Other: Glucose reference<br>* 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'<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the curve (IAUC) of postprandial blood glucose level |  | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycemic index, serving method, instant noodle, water content