Glycemic Response; SatietyNCT02688283
The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
A study testing Nutrient cluster in people with Glycemic Response; Satiety, run by PepsiCo Global R&D.
Trial summary
The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response; Satiety
- What is being tested?
- Nutrient cluster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females between the ages of 18 and 70 inclusive
- No chronic medications other than oral contraceptives
- Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
- Body weight stable in a 5 kg range in the 3 months prior to study entry
Who cannot join
- Pregnant or nursing a baby
- Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
- Adults unable to consent and prisoners
About this study
Official title: Randomized, Controlled, Cross-over Study Comparing The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.
- Conditions
- Glycemic Response; Satiety
- Being tested
- Nutrient cluster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient 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: Nutrient 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: Nutrient cluster |
| White-bread | Placebo comparator | 45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster Receives: Other: Nutrient cluster |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC) for glucose and insulin
Measured: 0-4 hours post consumption
Secondary outcomes (1)
AUC for the visual analog scale (VAS) ratings of satiety
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 posted23 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Response; SatietyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688283
- Sponsor's protocol ID
- PEP-1512
- Status last verified
- Sep 2018
- First submitted
- 17 Feb 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Cross-over Study Comparing The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
- ClinicalTrials.gov ID
- NCT02688283
- Acronym / sponsor ID
- PEP-1512
- Conditions
- Glycemic Response; Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 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.
The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.
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: Nutrient cluster56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber |
| Control-cluster | Placebo comparator | Other: Nutrient 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: Nutrient cluster45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males or females between the ages of 18 and 70 inclusive
- No chronic medications other than oral contraceptives
- Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
- Body weight stable in a 5 kg range in the 3 months prior to study entry
Key exclusion criteria (3 listed)
- Pregnant or nursing a baby
- Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
- Adults unable to consent and prisoners
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 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
area under the curve (AUC) for glucose and insulin
Time frame: 0-4 hours post consumption
1 secondary outcome
AUC for the visual analog scale (VAS) ratings of satiety
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 27 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Glycemic Response; Satiety
Recruiting
Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting
Glycemic Response; Satiety, Fasting, Time Restricted
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.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient cluster in people with Glycemic Response; Satiety, 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 4 inclusion and 3 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 27 Sep 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?
area under the curve (AUC) for glucose and insulin (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 27 Sep 2018.