Glycemic IndexNCT01536860
Glycemic Response Testing
A study testing Dietary Intervention in people with Glycemic Index and Glycemic Response, run by Mondelēz International, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index, Glycemic Response
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (not less than 40% males or females
- Non-smoker
- Aged 18 to 55 years
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
- Not allergic to mustard, dairy or soy
- Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
- Willing and able to provide written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Reading Scientific Services Limited (RSSL)
Reading, Berkshire, RG6 6BZ
About this study
Official title: Glycaemic Response Testing
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
- Conditions
- Glycemic Index, Glycemic Response
- Being tested
- Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
300 ml of liquid food product
Dietary InterventionOther
300 ml of liquid food product
Dietary InterventionOther
300 ml of liquid food product
| Study group | Role | What they receive |
|---|---|---|
| Control Test Drink | Placebo comparator | control drink Receives: Other: Dietary Intervention |
| Experimental Test Drink 1 | Experimental | control drink containing ingredient 1 Receives: Other: Dietary Intervention |
| Experimental Test Drink 2 | Experimental | Control drink containing ingredient 2 Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products
The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Responsible party
- Sponsor
- Investigators
- Valerie Hart, SCS, Dip, MICR, Principal investigator, RSSL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536860
- Sponsor's protocol ID
- P12-00794
- Status last verified
- Nov 2013
- First submitted
- 16 Feb 2012
- Last updated
- 27 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Response Testing
- ClinicalTrials.gov ID
- NCT01536860
- Acronym / sponsor ID
- P12-00794
- Conditions
- Glycemic Index, Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 27 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Test Drink | Placebo comparator | Other: Dietary Interventioncontrol drink |
| Experimental Test Drink 1 | Experimental | Other: Dietary Interventioncontrol drink containing ingredient 1 |
| Experimental Test Drink 2 | Experimental | Other: Dietary InterventionControl drink containing ingredient 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female (not less than 40% males or females
- Non-smoker
- Aged 18 to 55 years
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dietary Intervention300 ml of liquid food product | Other | Control Test Drink |
| Dietary Intervention300 ml of liquid food product | Other | Experimental Test Drink 1 |
| Dietary Intervention300 ml of liquid food product | Other | Experimental Test Drink 2 |
Primary outcome
Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products
Time frame: 0-120 minutes
The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Valerie Hart, SCS, Dip, MICR principal investigator
RSSL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Glycemic Index and Glycemic Response, run by Mondelēz International, Inc. at 1 site in United Kingdom.
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 8 inclusion and 0 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 27 Nov 2013. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products (time frame: 0-120 minutes). 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 27 Nov 2013.