HealthyNCT02625350
Glycemic Index of Instant Noodle With and Without Soup: Does Serving Method Have an Effect?
A study testing Instant noodle without soup, Instant noodle with soup and Glucose reference in people with Healthy, run by Nutrifood Research Center, Jakarta, Indonesia.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Instant noodle without soup, Instant noodle with soup and Glucose reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-40 years
- Fasting blood glucose 70-99 mg/dL
- Indonesians
Who cannot join
- 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
About this study
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.
Read the detailed description
Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.
- Conditions
- Healthy
- Being tested
- Instant noodle without soup, Instant noodle with soup, Glucose reference
- Keywords
- instant noodle, water content, glycemic index, serving method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant noodle without soupOther
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 soupOther
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 referenceOther
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'
| Study group | Role | What they receive |
|---|---|---|
| Instant noodle without soup | Experimental | Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes and drained Receives: Other: Instant noodle without soup |
| Instant noodle with soup | Experimental | 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 Receives: Other: Instant noodle with soup |
| Glucose reference | Experimental | 250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference Receives: Other: Glucose reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
Incremental area under the curve (IAUC) of postprandial blood glucose level
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrifood Research Center, Jakarta, Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanessa Yolanda, Ssi, Principal investigator, Nutrifood Research CenterLina Antono, MSc, Principal investigator, Nutrifood Research CenterAstri Kurniati, MAppSc, Study chair, Nutrifood Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625350
- Sponsor's protocol ID
- GI-noodle
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
PubMed 9743703Young 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.
PubMed 2759361Gregersen 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.
PubMed 2203255
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Index of Instant Noodle With and Without Soup: Does Serving Method Have an Effect?
- ClinicalTrials.gov ID
- NCT02625350
- Acronym / sponsor ID
- GI-noodle
- Conditions
- Healthy
- Keywords
- instant noodle, water content, glycemic index, serving method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nutrifood Research Center, Jakarta, IndonesiaIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instant noodle without soup | Experimental | Other: Instant noodle without soupInstant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes and drained |
| Instant noodle with soup | Experimental | Other: Instant noodle with soupInstant 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 |
| Glucose reference | Experimental | Other: Glucose reference250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20-40 years
- Fasting blood glucose 70-99 mg/dL
- Indonesians
Key exclusion criteria (7 listed)
- Having diabetes
- Smoking
- If women, pregnant or lactating
- Being allergic to food used in this study
- Having gastrointestinal disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instant noodle without soupFirst, 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' | Other | Instant noodle without soup |
| Instant noodle with soupFirst, 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' | Other | Instant noodle with soup |
| Glucose referenceFirst, 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' | Other | Glucose reference |
Primary outcome
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)
1 secondary outcome
Incremental area under the curve (IAUC) of postprandial blood glucose level
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 9743703Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
- Results publicationYoung 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
- Results publication: PubMed 2759361Torsdottir 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.
- Results publication: PubMed 2203255Gregersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Yolanda, Ssi principal investigator
Nutrifood Research Center
Lina Antono, MSc principal investigator
Nutrifood Research Center
Astri Kurniati, MAppSc study chair
Nutrifood Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Instant noodle without soup, Instant noodle with soup and Glucose reference in people with Healthy, run by Nutrifood Research Center, Jakarta, Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 2-h postprandial blood glucose level (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625350, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.