Glycemic ResponsesNCT02818452
Glycemic Impact of Oatmeal Plus OatWellXF28
A study testing Oatmeal + OatWell28XF, Oatmeal and Hot cereal in people with Glycemic Responses, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
The objective of this study is to determine the effect on glycemic responses of adding various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when added to a serving of Quaker Instant Oatmeal, would… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Responses
- What is being tested?
- Oatmeal + OatWell28XF, Oatmeal and Hot cereal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Aug 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.
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- 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 non-registered drug product within 30 d prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affecting the Glycemic Impact of Quaker Instant Oatmeal by Adding OatWell28XF: a Dose-Response Study
The objective of this study is to determine the effect on glycemic responses of adding various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least 20% less than that elicited by a β-glucan-free cereal.
- Conditions
- Glycemic Responses
- Being tested
- Oatmeal + OatWell28XF, Oatmeal, Hot cereal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oatmeal + OatWell28XFOther
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
OatmealOther
Hot cerealOther
| Study group | Role | What they receive |
|---|---|---|
| Oatmeal containing beta-glucan | Experimental | 27 g oatmeal Receives: Other: Oatmeal |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 1 | Experimental | 27.72g oatmeal Receives: Other: Oatmeal + OatWell28XF |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 2 | Experimental | 28.43g oatmeal Receives: Other: Oatmeal + OatWell28XF |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 3 | Experimental | 29.86g oatmeal Receives: Other: Oatmeal + OatWell28XF |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 4 | Experimental | 32.72g oatmeal Receives: Other: Oatmeal + OatWell28XF |
| Hot Cereal - Cream of Rice | Placebo comparator | 20g oatmeal Receives: Other: Hot cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose incremental area under the blood glucose response curve
Measured: 2 hours post consumption
Secondary outcomes (5)
Peak rise of blood glucose
Measured: 2 hours post consumption
Glucose concentrations and increments
Measured: 2 hours post consumption
Peak glucose concentration
Measured: 2 hours post consumption
Rate of decline of glucose
Measured: 2 hours post consumption
Time to return to baseline
Measured: 2 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponsesStudies 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)
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, MD, Principal investigator, GI Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818452
- Sponsor's protocol ID
- PEP-1523
- Status last verified
- Dec 2016
- First submitted
- 14 Jun 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affecting the Glycemic Impact of Quaker Instant Oatmeal by Adding OatWell28XF: a Dose-Response Study
- ClinicalTrials.gov ID
- NCT02818452
- Acronym / sponsor ID
- PEP-1523
- Conditions
- Glycemic Responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jun 2016 (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 objective of this study is to determine the effect on glycemic responses of adding various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least 20% less than that elicited by a β-glucan-free cereal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Oatmeal containing beta-glucan | Experimental | Other: Oatmeal27 g oatmeal |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 1 | Experimental | Other: Oatmeal + OatWell28XF27.72g oatmeal |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 2 | Experimental | Other: Oatmeal + OatWell28XF28.43g oatmeal |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 3 | Experimental | Other: Oatmeal + OatWell28XF29.86g oatmeal |
| Oatmeal containing beta-glucan + OatWell28XF Intervention 4 | Experimental | Other: Oatmeal + OatWell28XF32.72g oatmeal |
| Hot Cereal - Cream of Rice | Placebo comparator | Other: Hot cereal20g oatmeal |
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 (13 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 + OatWell28XFIntervention involves consumption of one cereal in the beginning of each visit of the crossover sequence | Other | Oatmeal containing beta-glucan + OatWell28XF Intervention 1, Oatmeal containing beta-glucan + OatWell28XF Intervention 2, Oatmeal containing beta-glucan + OatWell28XF Intervention 3, Oatmeal containing beta-glucan + OatWell28XF Intervention 4 |
| Oatmeal | Other | Oatmeal containing beta-glucan |
| Hot cereal | Other | Hot Cereal - Cream of Rice |
Primary outcome
Glucose incremental area under the blood glucose response curve
Time frame: 2 hours post consumption
5 secondary outcomes
Peak rise of blood glucose
Time frame: 2 hours post consumption
Glucose concentrations and increments
Time frame: 2 hours post consumption
Peak glucose concentration
Time frame: 2 hours post consumption
Rate of decline of glucose
Time frame: 2 hours post consumption
Time to return to baseline
Time frame: 2 hours post consumption
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 Dec 2016.
- 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.
Thomas Wolever, MD principal investigator
GI Laboratories
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 + OatWell28XF, Oatmeal and Hot cereal in people with Glycemic Responses, 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 13 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 Dec 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?
Glucose incremental area under the blood glucose response curve (time frame: 2 hours post consumption). 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 Dec 2016.