Glycemic ResponseNCT02616159
Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals
A study testing Oatmeal in people with Glycemic Response, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
The objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Oatmeal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jan 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- 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.
- Normal fasting serum glucose (<7.0mmol/L capillary corresponding to 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 surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-Blind Crossover Trial to Assess Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals
The objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals.
Read the detailed description
Participant eligibility will be screened at visit 1. The study will be a randomized, cross-over design. Participants will come to the study site on 5 separate occasions separated by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2 fasting blood samples will be collected, and further blood sampled will be taken over a 3-hour period post study product consumption.
- Conditions
- Glycemic Response
- Being tested
- Oatmeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OatmealOther
| Study group | Role | What they receive |
|---|---|---|
| Oatmeal 1 | Experimental | 40 g cereal Receives: Other: Oatmeal |
| Oatmeal2 | Experimental | 40 g cereal Receives: Other: Oatmeal |
| Oatmeal 3 | Experimental | 40 g cereal Receives: Other: Oatmeal |
| Ready to eat cereal | Placebo comparator | 32.2 g cereal Receives: Other: Oatmeal |
| Hot cereal | Placebo comparator | 28.8 g cereal Receives: Other: Oatmeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak rise of blood glucose
Measured: 3 hours post dose
Secondary outcomes (4)
Incremental area under the blood glucose and insulin response curves
Measured: 0-3 hours post dose
Peak rise of insulin
Measured: 0-3 hours post dose
Peak glucose and insulin concentrations
Measured: 0-3 hours post dose
Blood glucose and insulin concentrations at each time point over a 3hr period
Measured: 0-3 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
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
- 30 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
- NCT02616159
- Sponsor's protocol ID
- PEP-1519
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind Crossover Trial to Assess Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02616159
- Acronym / sponsor ID
- PEP-1519
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Nov 2015 (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 objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals.
Detailed description
Participant eligibility will be screened at visit 1. The study will be a randomized, cross-over design. Participants will come to the study site on 5 separate occasions separated by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2 fasting blood samples will be collected, and further blood sampled will be taken over a 3-hour period post study product consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oatmeal 1 | Experimental | Other: Oatmeal40 g cereal |
| Oatmeal2 | Experimental | Other: Oatmeal40 g cereal |
| Oatmeal 3 | Experimental | Other: Oatmeal40 g cereal |
| Ready to eat cereal | Placebo comparator | Other: Oatmeal32.2 g cereal |
| Hot cereal | Placebo comparator | Other: Oatmeal28.8 g cereal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- 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.
- Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
Key exclusion criteria (7 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 surgical event within 3 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 |
|---|---|---|
| Oatmeal | Other | Hot cereal, Oatmeal 1, Oatmeal 3, Oatmeal2, Ready to eat cereal |
Primary outcome
peak rise of blood glucose
Time frame: 3 hours post dose
4 secondary outcomes
Incremental area under the blood glucose and insulin response curves
Time frame: 0-3 hours post dose
Peak rise of insulin
Time frame: 0-3 hours post dose
Peak glucose and insulin concentrations
Time frame: 0-3 hours post dose
Blood glucose and insulin concentrations at each time point over a 3hr period
Time frame: 0-3 hours post dose
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 21 Jun 2016.
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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 Oatmeal in people with Glycemic 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 8 inclusion and 7 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 21 Jun 2016. 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?
peak rise of blood glucose (time frame: 3 hours post dose). 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 21 Jun 2016.