Glucose ResponseNCT01671878
Glucose and Insulin Responses to Test Foods
A study testing Reference Glucose, Test Food 1 (Cereal) and Test Food 2 (Biscuit) in people with Glucose Response and Insulin Response, run by Mondelēz International, Inc. at 1 site in Canada.
Trial summary
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Response, Insulin Response
- What is being tested?
- Reference Glucose, Test Food 1 (Cereal) and Test Food 2 (Biscuit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male \& half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
- Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
- Systolic blood pressure 100-150 mmHg inclusive
- Diastolic blood pressure 60-90 mmHg inclusive
- Resting heart rate 50-90 beats/min inclusive after 3 minute rest
- Able to refrain from eating legumes and drinking alcohol the day before each test session
Show all 12Show fewer
- Fasting triglycerides < 2.0 mmol/L (178 mg/dL)
- Fasting HDL cholesterol > 0.9 mmol/L (35 mg/dL) for males and > 1.1mmol/L (42 mg/dL) for females
- Fasting LDL cholesterol < 5.0 mmol/L (193 mg/dL)
- AST and ALT < 120% of upper limit of normal (ULN)
- hsCRP < 10 mg/L
- Urea and creatinine < 150% ULN
Who cannot join
- failure to meet any one of the inclusion criteria
- age less than 18 or over 45 years
- known history or AIDS, hepatitis, diabetes or a heart condition
- participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
- participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
- Food allergies of any kind
- General anaesthesia in the month prior to inclusion.
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.
- Conditions
- Glucose Response, Insulin Response
- Being tested
- Reference Glucose, Test Food 1 (Cereal), Test Food 2 (Biscuit)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference GlucoseOther
Test Food 1 (Cereal)Other
Test Food 2 (Biscuit)Other
| Study group | Role | What they receive |
|---|---|---|
| Reference Glucose | Other | Glucose standard Receives: Other: Reference Glucose |
| Test Food 1 | Experimental | Cereal Receives: Other: Test Food 1 (Cereal) |
| Test Food 2 | Experimental | Biscuit Receives: Other: Test Food 2 (Biscuit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose Response
Measured: 3 hours
Secondary outcomes (1)
Postprandial Insulin Response
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ResponseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671878
- Sponsor's protocol ID
- GIl1244
- Status last verified
- May 2013
- First submitted
- 21 Aug 2012
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
- ClinicalTrials.gov ID
- NCT01671878
- Acronym / sponsor ID
- GIl1244
- Conditions
- Glucose Response, Insulin Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Aug 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.
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Glucose | Other | Other: Reference GlucoseGlucose standard |
| Test Food 1 | Experimental | Other: Test Food 1 (Cereal)Cereal |
| Test Food 2 | Experimental | Other: Test Food 2 (Biscuit)Biscuit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male \& half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
- Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
- Systolic blood pressure 100-150 mmHg inclusive
- Diastolic blood pressure 60-90 mmHg inclusive
- Resting heart rate 50-90 beats/min inclusive after 3 minute rest
Key exclusion criteria (8 listed)
- failure to meet any one of the inclusion criteria
- age less than 18 or over 45 years
- known history or AIDS, hepatitis, diabetes or a heart condition
- participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
- participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
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 |
|---|---|---|
| Reference Glucose | Other | Reference Glucose |
| Test Food 1 (Cereal) | Other | Test Food 1 |
| Test Food 2 (Biscuit) | Other | Test Food 2 |
Primary outcome
Postprandial Glucose Response
Time frame: 3 hours
1 secondary outcome
Postprandial Insulin Response
Time frame: 3 hours
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 7 May 2013.
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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.
Thomas Wolever, MD, PhD principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference Glucose, Test Food 1 (Cereal) and Test Food 2 (Biscuit) in people with Glucose Response and Insulin Response, run by Mondelēz International, Inc. at 1 site in Canada.
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 12 inclusion and 8 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 7 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 Canada. 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?
Postprandial Glucose Response (time frame: 3 hours). 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 7 May 2013.