Peak Rise of Blood GlucoseNCT02692144
Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals
A study testing Test Cluster in people with Peak Rise of Blood Glucose, run by PepsiCo Global R&D.
Trial summary
This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Peak Rise of Blood Glucose
- What is being tested?
- Test Cluster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant females, 18-60 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
- -
About this study
Official title: Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals: A Randomized, Cross-over Study
This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with typical ingredients commonly used in commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the postprandial responses elicited by the Test-cluster was also compared with those after a portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25 healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained similar amounts of total carbohydrates, protein, fat and energy content. Each serving of Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.
On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal. Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60, 90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample. During the 4hr of the test, participants remained seated quietly. After the last blood sample participants were offered a snack and then allowed to leave.
- Conditions
- Peak Rise of Blood Glucose
- Being tested
- Test Cluster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ClusterOther
Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
| Study group | Role | What they receive |
|---|---|---|
| Test-cluster | Experimental | 56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber Receives: Other: Test Cluster |
| Control-cluster | Placebo comparator | 56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars Receives: Other: Test Cluster |
| White-bread | Placebo comparator | 47g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster Receives: Other: Test Cluster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak rise of blood glucose
Measured: 0-4 hours post consumption
Secondary outcomes (3)
Incremental area under the curve of blood glucose
Measured: 0-4 hours post consumption
Peak rise of serum insulin
Measured: 0-4 hours post consumption
Incremental area under the curve of serum insulin
Measured: 0-4 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 posted25 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peak Rise of Blood GlucoseStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, PhD, Principal investigator, GI Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692144
- Sponsor's protocol ID
- PEP-1511
- Status last verified
- Jan 2018
- First submitted
- 17 Feb 2016
- Last updated
- 5 Feb 2018
- 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 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals: A Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT02692144
- Acronym / sponsor ID
- PEP-1511
- Conditions
- Peak Rise of Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Feb 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.
This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with typical ingredients commonly used in commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the postprandial responses elicited by the Test-cluster was also compared with those after a portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25 healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained similar amounts of total carbohydrates, protein, fat and energy content. Each serving of Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.
On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal. Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60, 90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample. During the 4hr of the test, participants remained seated quietly. After the last blood sample participants were offered a snack and then allowed to leave.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test-cluster | Experimental | Other: Test Cluster56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber |
| Control-cluster | Placebo comparator | Other: Test Cluster56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars |
| White-bread | Placebo comparator | Other: Test Cluster47g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or non-pregnant females, 18-60 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 (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 |
|---|---|---|
| Test ClusterTest cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber | Other | Control-cluster, Test-cluster, White-bread |
Primary outcome
Peak rise of blood glucose
Time frame: 0-4 hours post consumption
3 secondary outcomes
Incremental area under the curve of blood glucose
Time frame: 0-4 hours post consumption
Peak rise of serum insulin
Time frame: 0-4 hours post consumption
Incremental area under the curve of serum insulin
Time frame: 0-4 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 5 Feb 2018.
- Individual participant dataSharing planned: No
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, PhD principal investigator
GI Laboratories
Questions about this trial
What is this clinical trial studying?
A study testing Test Cluster in people with Peak Rise of Blood Glucose, run by PepsiCo Global R&D.
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 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: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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: 0-4 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 5 Feb 2018.