Glycemic ResponseNCT02927015
Glucose Response From Antioxidant Rich Potato Chips
A study testing Purple Majesty potato chips, Mountain Rose potato chips and White potato chips in people with Glycemic Response, run by Purdue University.
Trial summary
Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Purple Majesty potato chips, Mountain Rose potato chips and White potato chips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25 non-smoker
Who cannot join
- BMI outside 18-25 smoker previous gastrointestinal disease or other disease
About this study
Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.
Read the detailed description
Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest phenolic-rich potato extracts decrease intestinal glucose transport. The aim is to determine if these effects extend to the the an in vivo situation. Specifically, the glycemic response following consumption of phenolic rich pigmented potatoes compared to white potatoes with lower phenolic content will be measured. Gastric emptying will also be measured to show the effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport and not gastric emptying rate.
- Conditions
- Glycemic Response
- Being tested
- Purple Majesty potato chips, Mountain Rose potato chips, White potato chips, Crackers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple Majesty potato chipsOther
Purple Majesty potato chips
Mountain Rose potato chipsOther
Mountain Rose potato chips
White potato chipsOther
White potato chips
CrackersOther
Crackers
| Study group | Role | What they receive |
|---|---|---|
| Purple Majesty potato chips | Experimental | Purple Majesty potato chips Receives: Other: Purple Majesty potato chips |
| Mountain Rose potato chips | Experimental | Mountain Rose potato chips Receives: Other: Mountain Rose potato chips |
| White potato chips | Experimental | White potato chips Receives: Other: White potato chips |
| Crackers | Experimental | Crackers Receives: Other: Crackers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
blood taken at 10, 20, 30, 60, and 120 minutes by finger prick
Measured: up to 2 hours
Gastric emptying
Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionJun 2016
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927015
- Sponsor's protocol ID
- 055-043
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Response From Antioxidant Rich Potato Chips
- ClinicalTrials.gov ID
- NCT02927015
- Acronym / sponsor ID
- 055-043
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Oct 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.
Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.
Detailed description
Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest phenolic-rich potato extracts decrease intestinal glucose transport. The aim is to determine if these effects extend to the the an in vivo situation. Specifically, the glycemic response following consumption of phenolic rich pigmented potatoes compared to white potatoes with lower phenolic content will be measured. Gastric emptying will also be measured to show the effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport and not gastric emptying rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Purple Majesty potato chips | Experimental | Other: Purple Majesty potato chipsPurple Majesty potato chips |
| Mountain Rose potato chips | Experimental | Other: Mountain Rose potato chipsMountain Rose potato chips |
| White potato chips | Experimental | Other: White potato chipsWhite potato chips |
| Crackers | Experimental | Other: CrackersCrackers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18-25 non-smoker
Key exclusion criteria (1 listed)
- BMI outside 18-25 smoker previous gastrointestinal disease or other disease
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 |
|---|---|---|
| Purple Majesty potato chipsPurple Majesty potato chips | Other | Purple Majesty potato chips |
| Mountain Rose potato chipsMountain Rose potato chips | Other | Mountain Rose potato chips |
| White potato chipsWhite potato chips | Other | White potato chips |
| CrackersCrackers | Other | Crackers |
Primary outcome
Blood Glucose
Time frame: up to 2 hours
blood taken at 10, 20, 30, 60, and 120 minutes by finger prick
Gastric emptying
Time frame: up to 4 hours
Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours
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 6 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Purple Majesty potato chips, Mountain Rose potato chips and White potato chips in people with Glycemic Response, run by Purdue University.
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 1 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 6 Oct 2016. 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. 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?
Blood Glucose (time frame: up to 2 hours). The study lists 2 primary outcomes in all. 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 6 Oct 2016.