Glycaemic Response MeasurementsNCT01687569
Glycaemic Responses to Cracker Snacks
A study testing Experimental Cracker Snack 1 and Experimental Cracker Snack 2 in people with Glycaemic Response Measurements, run by Mondelēz International, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Response Measurements
- What is being tested?
- Experimental Cracker Snack 1 and Experimental Cracker Snack 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Oct 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (not less than 40% Male)
- Aged 18 - 55 years
- Non Smokers
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
- Not allergic to wheat, mustard, dairy, or soy
- Have 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
About this study
Official title: Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack
The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.
- Conditions
- Glycaemic Response Measurements
- Being tested
- Control Cracker Snack, Experimental Cracker Snack 1, Experimental Cracker Snack 2
- Keywords
- Glycaemic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Cracker SnackOther
Base cracker snack
Experimental Cracker Snack 1Other
Cracker snack containing test ingredient 1
Experimental Cracker Snack 2Other
Cracker snack containing test ingredient 2
| Study group | Role | What they receive |
|---|---|---|
| Control Cracker | Placebo comparator | Base cracker snack Receives: Other: Control Cracker Snack |
| Experimental Cracker Snack 1 | Experimental | Cracker snack containing test ingredient 1 Receives: Other: Experimental Cracker Snack 1 |
| Experimental Cracker Snack 2 | Experimental | Cracker snack containing test ingredient 2 Receives: Other: Experimental Cracker Snack 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)
The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycaemic Response MeasurementsStudies 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
- 27 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
- Rungano Munyuki, Principal investigator, Reading Scientific Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687569
- Sponsor's protocol ID
- P12-05774
- Status last verified
- May 2013
- First submitted
- 14 Sep 2012
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack
- ClinicalTrials.gov ID
- NCT01687569
- Acronym / sponsor ID
- P12-05774
- Conditions
- Glycaemic Response Measurements
- Keywords
- Glycaemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 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.
The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Cracker | Placebo comparator | Other: Control Cracker SnackBase cracker snack |
| Experimental Cracker Snack 1 | Experimental | Other: Experimental Cracker Snack 1Cracker snack containing test ingredient 1 |
| Experimental Cracker Snack 2 | Experimental | Other: Experimental Cracker Snack 2Cracker snack containing test 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% Male)
- Aged 18 - 55 years
- Non Smokers
- 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 |
|---|---|---|
| Control Cracker SnackBase cracker snack | Other | Control Cracker |
| Experimental Cracker Snack 1Cracker snack containing test ingredient 1 | Other | Experimental Cracker Snack 1 |
| Experimental Cracker Snack 2Cracker snack containing test ingredient 2 | Other | Experimental Cracker Snack 2 |
Primary outcome
Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)
Time frame: 120 minutes
The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.
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 9 May 2013.
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.
Rungano Munyuki principal investigator
Reading Scientific Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Cracker Snack 1 and Experimental Cracker Snack 2 in people with Glycaemic Response Measurements, 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 9 May 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?
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?
Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC) (time frame: 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 9 May 2013.