Glycemic IndexNCT02278380
Different Glycemic Index (GI) Values in 7 Food Products
A study testing Low GI Standard Breakfast, Medium GI Standard Breakfast and Enfamama A+ 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 seven food products. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Low GI Standard Breakfast, Medium GI Standard Breakfast and Enfamama A+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2014to Jan 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant females at least 6 weeks postpartum, non-lactating and aged 21-60yrs old in both groups.
- They should not suffer from any chronic diseases.
- no known food allergy or intolerance.
- no medications known to affect glucose tolerance(excluding oral contraceptives). Note: stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
Who cannot join
- Age less than 21 years old and greater than 60 years old.
- known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- known history of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
- subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.,
- subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion and have no known food allergies.
- a major medical or surgical event requiring hospitalisation within the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-Vivo Glycemic Index (GI) and Insulinemic Index (II) Testing of 7 Test Foods in Total (5 Milk-based Beverage and 2 Standard Breakfast Items)
This study is initiated to investigate the glycemic index value of seven food products.
- Conditions
- Glycemic Index
- Being tested
- Low GI Standard Breakfast, Medium GI Standard Breakfast, Enfamama A+, Glucerna Triple Care, Dumex Precima
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GI Standard BreakfastOther
Low GI Standard Breakfast
Medium GI Standard BreakfastOther
Medium GI Standard Breakfast
Enfamama A+Other
Nutritional pregnant milk supplement
Glucerna Triple CareOther
Nutritional product for diabetics
Dumex PrecimaOther
Pregnant and lactation women milk powder
DiasipOther
Nutritional drinks for diabetics
Test productOther
Also called Not patented yet, cannot disclose name.
Test product not patented yet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | To compare the Glycemic Index value of seven test foods:
Low GI standard Breakfast Medium GI standard Breakfast Nutritional pregnant milk supplement Nutritional product for diabetics Pregnant and lactation women milk powder Nutritional drinks for diabetics Test product Receives: Other: Low GI Standard Breakfast; Other: Medium GI Standard Breakfast; Other: Enfamama A+; Other: Glucerna Triple Care; Other: Dumex Precima; Other: Diasip; Other: Test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index values of all seven products
Glycemic index values at 120 minutes post adminstration.
Measured: 120 minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Randomised
- 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
- NCT02278380
- Sponsor's protocol ID
- GDM.1.C/D
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2014
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Glycemic Index (GI) and Insulinemic Index (II) Testing of 7 Test Foods in Total (5 Milk-based Beverage and 2 Standard Breakfast Items)
- ClinicalTrials.gov ID
- NCT02278380
- Acronym / sponsor ID
- GDM.1.C/D
- 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
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Oct 2014 (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 seven food products.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Low GI Standard Breakfast, Other: Medium GI Standard Breakfast, Other: Enfamama A+, Other: Glucerna Triple Care, Other: Dumex Precima, Other: Diasip, Other: Test productTo compare the Glycemic Index value of seven test foods: Low GI standard Breakfast Medium GI standard Breakfast Nutritional pregnant milk supplement Nutritional product for diabetics Pregnant and lactation women milk powder Nutritional drinks for diabetics Test product |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or non-pregnant females at least 6 weeks postpartum, non-lactating and aged 21-60yrs old in both groups.
- They should not suffer from any chronic diseases.
- no known food allergy or intolerance.
- no medications known to affect glucose tolerance(excluding oral contraceptives). Note: stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
Key exclusion criteria (6 listed)
- Age less than 21 years old and greater than 60 years old.
- known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- known history of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
- subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.,
- subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion and have no known food allergies.
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 |
|---|---|---|
| Low GI Standard BreakfastLow GI Standard Breakfast | Other | Arm 1 |
| Medium GI Standard BreakfastMedium GI Standard Breakfast | Other | Arm 1 |
| Enfamama A+Nutritional pregnant milk supplement | Other | Arm 1 |
| Glucerna Triple CareNutritional product for diabetics | Other | Arm 1 |
| Dumex PrecimaPregnant and lactation women milk powder | Other | Arm 1 |
| DiasipNutritional drinks for diabetics | Other | Arm 1 |
| Test productAlso: Not patented yet, cannot disclose name.Test product not patented yet | Other | Arm 1 |
Primary outcome
Glycemic index values of all seven products
Time frame: 120 minutes post administration
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 13 Apr 2015.
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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 Low GI Standard Breakfast, Medium GI Standard Breakfast and Enfamama A+ 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 4 inclusion and 6 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 13 Apr 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 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 seven products (time frame: 120 minutes post administration). 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 13 Apr 2015.