Glycemic ResponseNCT03493022
Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
A study testing Test Granola in people with Glycemic Response and Insulinemic Response, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
The objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period. In addition, the subjective hunger response to these foods will be measured over 3 h. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Insulinemic Response, Subject Hunger Response
- What is being tested?
- Test Granola
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2017to 15 Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating females, 18-65 years of age, inclusive
- Body mass index (BMI) between 21.0 and 32.0 kg/m², inclusive, at screening (visit 1).
- No participation in a PepsiCo study at GI Labs for at least 6 months from signing the consent form or previously enrolled into a PepsiCo Granola RAG:SAG trial (PEP-1701, PEP-1711, PEP-1712).
- No participation in any clinical trial for at least 30 days from signing the consent form.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
- Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
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- Fasting serum glucose <7.0mmol/L or capillary whole blood glucose <6.3mmol/L.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Who cannot join
- Failure to meet any one of the inclusion criteria
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, 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.
- Major trauma or major surgical event within 6 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Lactose intolerance.
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- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- Change in body weight of >3.5kg within 4 weeks of the screening visit.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Exposure to any investigational drug product within 30 d prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period. In addition, the subjective hunger response to these foods will be measured over 3 h.
- Being tested
- Test Granola, Control Granola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test GranolaOther
50.5 Test Granola
Control GranolaOther
54.3 Control Granola
| Study group | Role | What they receive |
|---|---|---|
| Test Granola | Experimental | 50.5 g Test Granola Receives: Other: Test Granola |
| Control Granola | Placebo comparator | 54.3 Control Granola Receives: Other: Control Granola |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the blood glucose curve
Measured: 0-2 hours
Secondary outcomes (3)
incremental areas under the curve of blood glucose
Measured: 0-3 and 2-3 hours
incremental areas under the curve of serum insulin
Measured: 0-2 hours, 2-3 hours, 0-3 hours
subjective hunger response
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start25 Aug 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493022
- Sponsor's protocol ID
- PEP-1710
- Status last verified
- Apr 2018
- First submitted
- 31 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
- ClinicalTrials.gov ID
- NCT03493022
- Acronym / sponsor ID
- PEP-1710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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 objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period. In addition, the subjective hunger response to these foods will be measured over 3 h.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Granola | Experimental | Other: Test Granola50.5 g Test Granola |
| Control Granola | Placebo comparator | Other: Control Granola54.3 Control Granola |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or non-pregnant, non-lactating females, 18-65 years of age, inclusive
- Body mass index (BMI) between 21.0 and 32.0 kg/m², inclusive, at screening (visit 1).
- No participation in a PepsiCo study at GI Labs for at least 6 months from signing the consent form or previously enrolled into a PepsiCo Granola RAG:SAG trial (PEP-1701, PEP-1711, PEP-1712).
- No participation in any clinical trial for at least 30 days from signing the consent form.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
Key exclusion criteria (14 listed)
- Failure to meet any one of the inclusion criteria
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, 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.
- Major trauma or major surgical event within 6 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to 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 |
|---|---|---|
| Test Granola50.5 Test Granola | Other | Test Granola |
| Control Granola54.3 Control Granola | Other | Control Granola |
Primary outcome
Incremental area under the blood glucose curve
Time frame: 0-2 hours
3 secondary outcomes
incremental areas under the curve of blood glucose
Time frame: 0-3 and 2-3 hours
incremental areas under the curve of serum insulin
Time frame: 0-2 hours, 2-3 hours, 0-3 hours
subjective hunger response
Time frame: 0-3 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 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Granola in people with Glycemic Response and Insulinemic Response, run by PepsiCo Global R&D 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 10 inclusion and 14 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 10 Apr 2018. 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. 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?
Incremental area under the blood glucose curve (time frame: 0-2 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 10 Apr 2018.