- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625350
Glycemic Index of Instant Noodle With and Without Soup: Does Serving Method Have an Effect?
December 4, 2015 updated by: Nutrifood Research Center, Jakarta, Indonesia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Instant noodle without soup
Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes and drained
|
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'
|
|
Experimental: Instant noodle with soup
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
|
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'
|
|
Experimental: Glucose reference
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 reference 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 |
|---|---|---|
|
Changes in 2-h postprandial blood glucose level
Time Frame: through study completion, an average of 1 month
|
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 |
Time Frame |
|---|---|
|
Incremental area under the curve (IAUC) of postprandial blood glucose level
Time Frame: through study completion, an average of 1 month
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
December 1, 2015
First Submitted That Met QC Criteria
December 4, 2015
First Posted (Estimate)
December 9, 2015
Study Record Updates
Last Update Posted (Estimate)
December 9, 2015
Last Update Submitted That Met QC Criteria
December 4, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- GI-noodle
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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