Study Focus 1:Glycaemic IndexNCT01341769
Blood Glucose and Insulin Responses to Snack Food Products
A study testing Dietary Intervention in people with Study Focus 1:Glycaemic Index and Study Focus 2:Glycaemic Response, run by Mondelēz International, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Study Focus 1:Glycaemic Index, Study Focus 2:Glycaemic Response, Study Focus 3:Insulinemic Response
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jul 2011
- 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% males or females
- Non-smoker
- Aged 18 to 55 years
- Have a body mass index between 18.5 to 29.99 kg/m2
- Fasting blood glucose (finger-stick) >3.3 and <5.6 mmol/L (Visit 2)
- Two-hour OGTT glucose (finger-stick) <7.8 mmol/L (Visit 2)
- Willing and able to provide written informed consent
Who cannot join
- Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
- Any significant concurrent illness
- History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
- Have assessed an investigational product for GI in the last 72 hours.
- Concurrent participation in any other safety study
- History of diabetes, hepatitis, AIDS, anaemia or a heart condition
Show all 10Show fewer
- The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
- Had any type of gastrointestinal surgery, including gastric bypass
- Having consumed anything apart from plain water in the 12 hours prior to each test
- Have been medically diagnosed as having high blood pressure or heart disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Reading Scientific Services Limited
Reading, Berkshire, RG6 6BZ
About this study
Official title: A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food
The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Dietary InterventionOther
Dietary InterventionOther
Dietary InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control Test Food | Placebo comparator | Snack base Receives: Other: Dietary Intervention |
| Experimental Test Food 1 | Experimental | Snack Base containing ingredient 1 Receives: Other: Dietary Intervention |
| Experimental Test Food 2 | Experimental | Snack base containing ingredient 2 Receives: Other: Dietary Intervention |
| Experimental Test Food 3 | Experimental | Snack base containing ingredients 1 and 2 Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
Measured: 0-120 minutes
Secondary outcomes (4)
Glycaemic index of experimental test foods compared to that of control test food using capillary blood
Measured: 0-120 minutes
Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood
Measured: 0-180 minutes
Measure insulin in venous plasma
Measured: 0-180 minutes
Measure C-peptide in venous plasma
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: Test ingredient production did not meet specification
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Focus 1:Glycaemic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Investigators
- Valerie Hart, SCS, Dip, MICR, Study director, Reading Scientific Services LimitedDr. Suzana Louth, Principal investigator, Reading Scientific Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341769
- Sponsor's protocol ID
- P10-08857 version 01
- Status last verified
- Jan 2019
- First submitted
- 22 Apr 2011
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food
- ClinicalTrials.gov ID
- NCT01341769
- Acronym / sponsor ID
- P10-08857 version 01
- Conditions
- Study Focus 1:Glycaemic Index, Study Focus 2:Glycaemic Response, Study Focus 3:Insulinemic Response
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Test ingredient production did not meet specification
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 26 Apr 2011 (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 assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Test Food | Placebo comparator | Other: Dietary InterventionSnack base |
| Experimental Test Food 1 | Experimental | Other: Dietary InterventionSnack Base containing ingredient 1 |
| Experimental Test Food 2 | Experimental | Other: Dietary InterventionSnack base containing ingredient 2 |
| Experimental Test Food 3 | Experimental | Other: Dietary InterventionSnack base containing ingredients 1 and 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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
- Fasting blood glucose (finger-stick) >3.3 and <5.6 mmol/L (Visit 2)
Key exclusion criteria (10 listed)
- Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
- Any significant concurrent illness
- History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
- Have assessed an investigational product for GI in the last 72 hours.
- Concurrent participation in any other safety study
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 Intervention | Other | Control Test Food |
| Dietary Intervention | Other | Experimental Test Food 1 |
| Dietary Intervention | Other | Experimental Test Food 2 |
| Dietary Intervention | Other | Experimental Test Food 3 |
Primary outcome
Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
Time frame: 0-120 minutes
4 secondary outcomes
Glycaemic index of experimental test foods compared to that of control test food using capillary blood
Time frame: 0-120 minutes
Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood
Time frame: 0-180 minutes
Measure insulin in venous plasma
Time frame: 0-180 minutes
Measure C-peptide in venous plasma
Time frame: 0-180 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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 study director
Reading Scientific Services Limited
Dr. Suzana Louth 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 Dietary Intervention in people with Study Focus 1:Glycaemic Index and Study Focus 2:Glycaemic 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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 31 Jan 2019. 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 was withdrawn before enrolling participants, so there are no results.
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 index of experimental test foods compared to that of control test food using venous plasma. (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 31 Jan 2019.