Glycemic IndexNCT01679704
Determination of Glycemic Index (GI) of Ten Food Products
A study testing Food products in people with Glycemic Index, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial summary
This study is initiated to investigate the glycemic index value of ten food products. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Food products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2012to Apr 2012
- 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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-pregnant females (at least 6 weeks postpartum, non-lactating)
- Age between 21 to 60 years
Who cannot join
- Suffering from any chronic diseases.
- Suffering from gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism and excretion.
- History of diabtes mellitus or use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- History of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
- Current use of medication that may interfere with the digestion and nutrient absorption (for examples steriods, protease inhibitors or antipsychotics medications).
- Current use of medication known to affect glucose tolerance (excluding oral contraceptives).
- Known food allergy or intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
This study is initiated to investigate the glycemic index value of ten food products.
- Conditions
- Glycemic Index
- Being tested
- Food products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food productsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Food products | Other | Ten food products will be given to all subjects Receives: Dietary Supplement: Food products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index values of all ten products
Glycemic index values at 120 minutes post adminstration.
Measured: 120 minutes post adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kalpana Bhaskaran, Dr, Principal investigator, Temasek Polytechnic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679704
- Sponsor's protocol ID
- GIS.2012
- Status last verified
- Aug 2014
- First submitted
- 30 Aug 2012
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Glycemic Index (GI) of Ten Food Products
- ClinicalTrials.gov ID
- NCT01679704
- Acronym / sponsor ID
- GIS.2012
- Conditions
- Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Sep 2012 (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.
This study is initiated to investigate the glycemic index value of ten food products.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food products | Other | Dietary Supplement: Food productsTen food products will be given to all subjects |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy non-pregnant females (at least 6 weeks postpartum, non-lactating)
- Age between 21 to 60 years
Key exclusion criteria (7 listed)
- Suffering from any chronic diseases.
- Suffering from gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism and excretion.
- History of diabtes mellitus or use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- History of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
- Current use of medication that may interfere with the digestion and nutrient absorption (for examples steriods, protease inhibitors or antipsychotics medications).
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 |
|---|---|---|
| Food products | Dietary supplement | Food products |
Primary outcome
Glycemic index values of all ten products
Time frame: 120 minutes post adminstration
Glycemic index values at 120 minutes post adminstration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
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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.
Kalpana Bhaskaran, Dr principal investigator
Temasek Polytechnic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food products in people with Glycemic Index, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
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 2 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: finished, as of the sponsor's last update on 4 Aug 2014. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic index values of all ten products (time frame: 120 minutes post adminstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2014.