Glycemic ResponseNCT02037854
PEP-1324: Glycemic Response Testing
A study testing Nutrient formulation in people with Glycemic Response, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses. 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?
- Nutrient formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jun 2014
- 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
- Subject is 18-75 years of age
- Subject is male or non-pregnant females, 18-75 years of age, inclusive
- Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- Subject has to be non-smoker.
- Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Subject is 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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- Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Janice Campbell contact
Canada1 site, 1 recruiting
- Recruiting
GI Labs
Toronto, Ontario, M5C 2N8
Janice Campbell, JCampbell@gilabs.com
About this study
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.
- Conditions
- Glycemic Response
- Being tested
- Nutrient formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient formulationOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A nutrient formulation without the active ingredient Receives: Other: Nutrient formulation |
| Nutrient formulation | Experimental | Nutrient formulations with variable amounts of active ingredients. Receives: Other: Nutrient formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the blood glucose response cruve
Measured: 0-2 hours
Secondary outcomes (2)
peak blood glucose
Measured: 0-2 hours
peak insulin
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
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
- 12 participants (estimated)
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
- NCT02037854
- Sponsor's protocol ID
- PEP-1324
- Status last verified
- Oct 2014
- First submitted
- 13 Jan 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEP-1324: Glycemic Response Testing
- ClinicalTrials.gov ID
- NCT02037854
- Acronym / sponsor ID
- PEP-1324
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 16 Jan 2014 (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 purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Nutrient formulationA nutrient formulation without the active ingredient |
| Nutrient formulation | Experimental | Other: Nutrient formulationNutrient formulations with variable amounts of active ingredients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 18-75 years of age
- Subject is male or non-pregnant females, 18-75 years of age, inclusive
- Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- Subject has to be non-smoker.
- Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Nutrient formulation | Other | Nutrient formulation, Placebo |
Primary outcome
Incremental area under the blood glucose response cruve
Time frame: 0-2 hours
2 secondary outcomes
peak blood glucose
Time frame: 0-2 hours
peak insulin
Time frame: 0-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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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.
Janice Campbell contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient formulation 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice Campbell (JCampbell@gilabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental area under the blood glucose response cruve (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 30 Oct 2014.