Blood Glucose; Subjective Hunger, InsulinNCT03091946
Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight
A study testing Overnight oats with additional dried fruits, nuts and seeds and Cooked cream of rice with additional dried fruits, nuts and seeds in people with Blood Glucose; Subjective Hunger, Insulin, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
The purpose of this study is to compare the glucose, insulin and subjective hunger responses elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds cooked just prior to its consumption. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose; Subjective Hunger, Insulin
- What is being tested?
- Overnight oats with additional dried fruits, nuts and seeds and Cooked cream of rice with additional dried fruits, nuts and seeds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 31 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 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) between 20.00 and 34.99 kg/m² inclusive 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 Richardson Centre. Failure to comply will result in a rescheduled test visit.
- Normal fasting serum glucose (<6.3mmol/L).
- Willing to abstain from alcohol consumption for 24 h prior to all test visits.
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- Willing to 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. Jones, the director of the Richardson Centre, 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.
- Known to be pregnant or lactating
- Unwillingness or inability to comply with the experimental procedures and to follow Richardson Centre safety guidelines.
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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.
- Participation in any clinical trial 30 days prior to the start of this study.
- Participation in a PepsiCo clinical study in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight in Skim Milk Versus Cream of Rice With Additional Dried Fruits, Nuts and Seeds
The purpose of this study is to compare the glucose, insulin and subjective hunger responses elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds cooked just prior to its consumption.
- Being tested
- Overnight oats with additional dried fruits, nuts and seeds, Cooked cream of rice with additional dried fruits, nuts and seeds
- Keywords
- Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight oats with additional dried fruits, nuts and seedsOther
Oatmeal
Cooked cream of rice with additional dried fruits, nuts and seedsOther
Cooked cream of rice
| Study group | Role | What they receive |
|---|---|---|
| Cooked cream of rice | Placebo comparator | Cream of rice with additional dried fruits, nuts and seeds cooked just prior to its consumption and served with skim milk as a beverage Receives: Other: Cooked cream of rice with additional dried fruits, nuts and seeds |
| Overnight oats | Experimental | Oats with additional dried fruits, nuts and seeds soaked overnight in skim milk Receives: Other: Overnight oats with additional dried fruits, nuts and seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental area under the blood glucose curve
The primary objective of this study is to compare the incremental area under the blood glucose curve from 0-120 min elicited by available carbohydrate matched portions of oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds.
Measured: 0-120 min
Secondary outcomes (3)
subjective hunger using Visual Analog Scale (VAS)
subjective hunger will be measured using VAS below baseline at 120, 180 and 240 min,
Measured: below baseline at 120, 180 and 240 min
incremental areas under the curve (iAUC) of blood glucose
incremental areas under the curve (iAUC) of blood glucose from 0-180 min
Measured: 0-180 min
iAUC of serum insulin
iAUC of serum insulin from 0-120 min and 0-180 min
Measured: 0-120 min and 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Aug 2017
- Primary completion1 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose; Subjective Hunger, InsulinStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091946
- Sponsor's protocol ID
- PEP-1703
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight in Skim Milk Versus Cream of Rice With Additional Dried Fruits, Nuts and Seeds
- ClinicalTrials.gov ID
- NCT03091946
- Acronym / sponsor ID
- PEP-1703
- Keywords
- Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Mar 2017 (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 purpose of this study is to compare the glucose, insulin and subjective hunger responses elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds cooked just prior to its consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooked cream of rice | Placebo comparator | Other: Cooked cream of rice with additional dried fruits, nuts and seedsCream of rice with additional dried fruits, nuts and seeds cooked just prior to its consumption and served with skim milk as a beverage |
| Overnight oats | Experimental | Other: Overnight oats with additional dried fruits, nuts and seedsOats with additional dried fruits, nuts and seeds soaked overnight in skim milk |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) between 20.00 and 34.99 kg/m² inclusive 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 Richardson Centre. Failure to comply will result in a rescheduled test visit.
- Normal fasting serum glucose (<6.3mmol/L).
Key exclusion criteria (16 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. Jones, the director of the Richardson Centre, 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.
- Known to be pregnant or lactating
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 |
|---|---|---|
| Overnight oats with additional dried fruits, nuts and seedsOatmeal | Other | Overnight oats |
| Cooked cream of rice with additional dried fruits, nuts and seedsCooked cream of rice | Other | Cooked cream of rice |
Primary outcome
incremental area under the blood glucose curve
Time frame: 0-120 min
The primary objective of this study is to compare the incremental area under the blood glucose curve from 0-120 min elicited by available carbohydrate matched portions of oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds.
3 secondary outcomes
subjective hunger using Visual Analog Scale (VAS)
Time frame: below baseline at 120, 180 and 240 min
incremental areas under the curve (iAUC) of blood glucose
Time frame: 0-180 min
iAUC of serum insulin
Time frame: 0-120 min and 0-180 min
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 1 Feb 2018.
- Individual participant dataSharing planned: Undecided
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.
Peter Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight oats with additional dried fruits, nuts and seeds and Cooked cream of rice with additional dried fruits, nuts and seeds in people with Blood Glucose; Subjective Hunger, Insulin, 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 9 inclusion and 16 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 1 Feb 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: 0-120 min). 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 1 Feb 2018.