Glycemic ResponseNCT03066713
Post-prandial Glucose Response From Phytochemical Rich Potato Products
A study testing Skin Off French Fry, Skin On French Fry and Hash brown in people with Glycemic Response and Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
Assess the impact of high antioxidant potato products on postprandial glycemic response and subsequent appetite and food intake. 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, Appetitive Behavior
- What is being tested?
- Skin Off French Fry, Skin On French Fry and Hash brown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 25 Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-25, male or female
Who cannot join
- BMI outside 18.5-25
Trial locations and contacts
1 site in 1 country.
About this study
Assess the impact of high antioxidant potato products on postprandial glycemic response and subsequent appetite and food intake.
Read the detailed description
Preliminary results from anthocyanin rich potato products suggest that a reduced postprandial glycemic response might be expected from certain types of potato products and that phenolic antioxidants may play a critical role in predicting the physiological response from potato products. Further, if consumed early in the day, such as at breakfast, a reduced glycemic response may serve to mitigate appetite and food consumption later in the day. Investigators aim to better understand how characteristics of commercial potato products (i.e. frozen potato products) with different phenolic profiles and content, may alter postprandial glycemic response and subsequent appetitive behavior. Specifically, investigators will assess the glycemic response from a serving of potato products in the morning using continuous glucose monitoring. Further, appetite and subsequent food consumption later in the day will be assessed through appetite logs and continuous glucose monitoring.
- Conditions
- Glycemic Response, Appetitive Behavior
- Being tested
- Skin Off French Fry, Skin On French Fry, Hash brown, Carbohydrate control
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Off French FryOther
Skin Off French Fries will be provided at breakfast and lunch
Skin On French FryOther
Skin On French Fries will be provided at breakfast and lunch
Hash brownOther
Hash brown potatoes will be provided at breakfast and lunch.
Carbohydrate controlOther
A pancake will be provided at breakfast, and pretzels will be provided at lunch.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: A | Experimental | Skin On French Fry - breakfast Skin On French Fry - lunch Mashed Potatoes - dinner Receives: Other: Skin On French Fry |
| Experimental: B | Experimental | Skin Off French Fry - breakfast Skin Off French Fry - lunch Mashed Potatoes - dinner Receives: Other: Skin Off French Fry |
| Experimental: C | Experimental | Hash brown - breakfast Hash brown - lunch Mashed Potato - dinner Receives: Other: Hash brown |
| Experimental: D | Experimental | Pancake - breakfast Pretzels - lunch Macaroni - dinner Receives: Other: Carbohydrate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose over 24 hours
Samples taken every 5 minutes for 24 hours by a continuous glucose monitor
Measured: 24 hours
Secondary outcomes (1)
Appetite
Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on the same day as the feeding intervention
Measured: Every hour for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start31 Jan 2017
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066713
- Sponsor's protocol ID
- 055-046
- Status last verified
- Jan 2018
- First submitted
- 21 Feb 2017
- Last updated
- 18 Jan 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 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-prandial Glucose Response From Phytochemical Rich Potato Products
- ClinicalTrials.gov ID
- NCT03066713
- Acronym / sponsor ID
- 055-046
- Conditions
- Glycemic Response, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 28 Feb 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.
Assess the impact of high antioxidant potato products on postprandial glycemic response and subsequent appetite and food intake.
Detailed description
Preliminary results from anthocyanin rich potato products suggest that a reduced postprandial glycemic response might be expected from certain types of potato products and that phenolic antioxidants may play a critical role in predicting the physiological response from potato products. Further, if consumed early in the day, such as at breakfast, a reduced glycemic response may serve to mitigate appetite and food consumption later in the day. Investigators aim to better understand how characteristics of commercial potato products (i.e. frozen potato products) with different phenolic profiles and content, may alter postprandial glycemic response and subsequent appetitive behavior. Specifically, investigators will assess the glycemic response from a serving of potato products in the morning using continuous glucose monitoring. Further, appetite and subsequent food consumption later in the day will be assessed through appetite logs and continuous glucose monitoring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: A | Experimental | Other: Skin On French FrySkin On French Fry - breakfast Skin On French Fry - lunch Mashed Potatoes - dinner |
| Experimental: B | Experimental | Other: Skin Off French FrySkin Off French Fry - breakfast Skin Off French Fry - lunch Mashed Potatoes - dinner |
| Experimental: C | Experimental | Other: Hash brownHash brown - breakfast Hash brown - lunch Mashed Potato - dinner |
| Experimental: D | Experimental | Other: Carbohydrate controlPancake - breakfast Pretzels - lunch Macaroni - dinner |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18.5-25, male or female
Key exclusion criteria (1 listed)
- BMI outside 18.5-25
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 |
|---|---|---|
| Skin Off French FrySkin Off French Fries will be provided at breakfast and lunch | Other | Experimental: B |
| Skin On French FrySkin On French Fries will be provided at breakfast and lunch | Other | Experimental: A |
| Hash brownHash brown potatoes will be provided at breakfast and lunch. | Other | Experimental: C |
| Carbohydrate controlA pancake will be provided at breakfast, and pretzels will be provided at lunch. | Other | Experimental: D |
Primary outcome
Change in Blood Glucose over 24 hours
Time frame: 24 hours
Samples taken every 5 minutes for 24 hours by a continuous glucose monitor
1 secondary outcome
Appetite
Time frame: Every hour for 24 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 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Off French Fry, Skin On French Fry and Hash brown in people with Glycemic Response and Appetitive Behavior, run by Purdue University at 1 site in United States.
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 18 Jan 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 United States. 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. 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?
Change in Blood Glucose over 24 hours (time frame: 24 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 18 Jan 2018.