HealthyNCT02625363
Water Intake and Glycemic Response : Preliminary Study
A study testing Glucose Ref - Std, Glucose Ref and 450 ml water and White Bread with 250 ml water in people with Healthy, run by Nutrifood Research Center, Jakarta, Indonesia at 1 site in Indonesia.
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. 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?
- Glucose Ref - Std, Glucose Ref and 450 ml water and White Bread with 250 ml water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 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
Trial locations and contacts
1 site in 1 country.
Vanessa Yolanda, SSi contact
Lina Antono, MSc contact
Indonesia1 site, 1 recruiting
- Recruiting
PT Nutrifood Indonesia
Jakarta, DKI Jakarta, 13920
Astri Kurniati, MAppSc, astri@nutrifood.co.id
About this study
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.
Read the detailed description
Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.
- Conditions
- Healthy
- Being tested
- Glucose Ref - Std, Glucose Ref and 450 ml water, White Bread with 250 ml water, White Bread and 700 ml water, White Bread with 125 ml water (twice)
- Keywords
- Glycemic Index, Water Intake, Glycemic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Ref - StdOther
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 waterOther
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 waterOther
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 waterOther
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)Other
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'
| Study group | Role | What they receive |
|---|---|---|
| Glucose Ref - Std | Experimental | 250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference Receives: Other: Glucose Ref - Std |
| Glucose Ref and 450 ml water | Experimental | 250 ml glucose solution with 50 gram available carbohydrate per serving. Sample was consumed with additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption Receives: Other: Glucose Ref and 450 ml water |
| White Bread with 250 ml water | Experimental | White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption Receives: Other: White Bread with 250 ml water |
| White Bread and 700 ml water | Experimental | White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption. Moreover, subjects given additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption Receives: Other: White Bread and 700 ml water |
| White Bread with 125 ml water (twice) | Experimental | Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes Receives: Other: White Bread with 125 ml water (twice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 h postprandial blood glucose level (Glycemic Response)
Measured: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
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.
Measured: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
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 startNov 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
- Single blind
- Who is masked
- Participant
- 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 CenterAstri Kurniati, MAppSc, Study chair, Nutrifood Research CenterLina Antono, MSc, Principal investigator, Nutrifood Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625363
- Sponsor's protocol ID
- Nutrifood
- Status last verified
- Dec 2015
- First submitted
- 16 Nov 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
- Water Intake and Glycemic Response : Preliminary Study
- ClinicalTrials.gov ID
- NCT02625363
- Acronym / sponsor ID
- Nutrifood
- Conditions
- Healthy
- Keywords
- Glycemic Index, Water Intake, Glycemic Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nutrifood Research Center, Jakarta, IndonesiaIndustry (pharma, biotech, devices)
- Study start
- Nov 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 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.
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
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Glucose Ref - Std | Experimental | Other: Glucose Ref - Std250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference |
| Glucose Ref and 450 ml water | Experimental | Other: Glucose Ref and 450 ml water250 ml glucose solution with 50 gram available carbohydrate per serving. Sample was consumed with additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption |
| White Bread with 250 ml water | Experimental | Other: White Bread with 250 ml waterWhite bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption |
| White Bread and 700 ml water | Experimental | Other: White Bread and 700 ml waterWhite bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption. Moreover, subjects given additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption |
| White Bread with 125 ml water (twice) | Experimental | Other: 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 |
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 |
|---|---|---|
| Glucose Ref - StdFirst, 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' | Other | Glucose Ref - Std |
| Glucose Ref and 450 ml waterFirst, 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 | Other | Glucose Ref and 450 ml water |
| White Bread with 250 ml waterFirst, 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' | Other | White Bread with 250 ml water |
| White Bread and 700 ml waterSample 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' | Other | White Bread and 700 ml water |
| 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' | Other | White Bread with 125 ml water (twice) |
Primary outcome
2 h postprandial blood glucose level (Glycemic Response)
Time frame: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
Glycemic index value of meal (white bread)
Time frame: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
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.
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.
- BackgroundYoung 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
- Background: 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.
- Background: 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 contact
Lina Antono, MSc contact
Vanessa Yolanda, SSi principal investigator
Nutrifood Research Center
Astri Kurniati, MAppSc study chair
Nutrifood Research Center
Lina Antono, MSc principal investigator
Nutrifood Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Ref - Std, Glucose Ref and 450 ml water and White Bread with 250 ml water in people with Healthy, run by Nutrifood Research Center, Jakarta, Indonesia at 1 site in 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.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Vanessa Yolanda, SSi (vanessa.yolanda@nutrifood.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 h postprandial blood glucose level (Glycemic Response) (time frame: fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min). The study lists 2 primary outcomes in all. 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 NCT02625363, 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.