DiabetesGINCT01053793
Glycemic Index and Polyphenol Bioavailability of Potatoes
A study testing Glycemic response to different varieties of potatoes in people with Diabetes and Insulin Resistance, run by Guelph Food Research Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine the glycemic index of four varieties of potatoes and to determine the bioavailability of polyphenols contained in these potatoes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Insulin Resistance
- What is being tested?
- Glycemic response to different varieties of potatoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Mar 2010
- 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
- healthy, non-smoker on no medication
- normal glucose tolerance
- willing to have a catheter inserted in forearm
Who cannot join
- abnormal glucose tolerance
- abnormal BMI
- on medication for a chronic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Measure the Glycemic Index and Polyphenol Bioavailability of Four Different Varieties of Potato.
The purpose of this study is to determine the glycemic index of four varieties of potatoes and to determine the bioavailability of polyphenols contained in these potatoes.
Read the detailed description
Ten healthy persons will have a fasting blood sample drawn and asked to randomly consume a 50g glucose drink (2 occasions), or 50g carbohydrate equivalent of cooked purple, red, yellow and white potatoes. Further blood samples will be obtained at 15,30, 45, 60, 90, 120, 180, 240 mins. Bloods from the first 2 hours will be analyzed for glucose and insulin to determine the glycemic response. Hourly blood samples will be analyzed for polyphenol to determine the bioavailability of polyphenols from the different potato variety. Urine samples will be collected before ingestion of the food items and again at 4 hours, and will be used to determine polyphenol bioavailability.
- Conditions
- Diabetes, Insulin Resistance
- Being tested
- Glycemic response to different varieties of potatoes
- Keywords
- Glycemic index, Anthocyanin, Potato, Polyphenol
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic response to different varieties of potatoesOther
Also called Purple potato, Red potato, White potato, Yellow potaot
the glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard
| Study group | Role | What they receive |
|---|---|---|
| Glucose Standard | Active comparator | Not described Receives: Other: Glycemic response to different varieties of potatoes |
| Potato Variety | Experimental | Not described Receives: Other: Glycemic response to different varieties of potatoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Measured: 2 hrs
Secondary outcomes (1)
Bioavailability of polyphenols from potatoes
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guelph Food Research Centre
- Sponsor type
- Other government
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Investigators
- Dan Ramdath, PhD, Principal investigator, Agriculture and Agri-Food CanadaMaggie Laidlaw, PhD, Study director, Nutracource Diagnostics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053793
- Sponsor's protocol ID
- 09-11-004
- Other IDs
- GFRC 09-11-004
- Acronym
- GI
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2010
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolever TM, Brand-Miller JC, Abernethy J, Astrup A, Atkinson F, Axelsen M, Bjorck I, Brighenti F, Brown R, Brynes A, Casiraghi MC, Cazaubiel M, Dahlqvist L, Delport E, Denyer GS, Erba D, Frost G, Granfeldt Y, Hampton S, Hart VA, Hatonen KA, Henry CJ, Hertzler S, Hull S, Jerling J, Johnston KL, Lightowler H, Mann N, Morgan L, Panlasigui LN, Pelkman C, Perry T, Pfeiffer AF, Pieters M, Ramdath DD, Ramsingh RT, Robert SD, Robinson C, Sarkkinen E, Scazzina F, Sison DC, Sloth B, Staniforth J, Tapola N, Valsta LM, Verkooijen I, Weickert MO, Weseler AR, Wilkie P, Zhang J. Measuring the glycemic index of foods: interlaboratory study. Am J Clin Nutr. 2008 Jan;87(1):247S-257S. doi: 10.1093/ajcn/87.1.247S.
PubMed 18175765Ramdath DD, Isaacs RL, Teelucksingh S, Wolever TM. Glycaemic index of selected staples commonly eaten in the Caribbean and the effects of boiling v. crushing. Br J Nutr. 2004 Jun;91(6):971-7. doi: 10.1079/bjn20041125.
PubMed 15182400Wolever TM, Vorster HH, Bjorck I, Brand-Miller J, Brighenti F, Mann JI, Ramdath DD, Granfeldt Y, Holt S, Perry TL, Venter C, Xiaomei Wu. Determination of the glycaemic index of foods: interlaboratory study. Eur J Clin Nutr. 2003 Mar;57(3):475-82. doi: 10.1038/sj.ejcn.1601551.
PubMed 12627186Wolever TM, Isaacs RL, Ramdath DD. Lower diet glycaemic index in African than South Asian men in Trinidad and Tobago. Int J Food Sci Nutr. 2002 Jul;53(4):297-303. doi: 10.1080/09637480220138142.
PubMed 12090025
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Measure the Glycemic Index and Polyphenol Bioavailability of Four Different Varieties of Potato.
- ClinicalTrials.gov ID
- NCT01053793
- Acronym / sponsor ID
- GI / 09-11-004
- Conditions
- Diabetes, Insulin Resistance
- Keywords
- Glycemic index, Anthocyanin, Potato, Polyphenol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guelph Food Research CentreOther government
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Jan 2010 (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 determine the glycemic index of four varieties of potatoes and to determine the bioavailability of polyphenols contained in these potatoes.
Detailed description
Ten healthy persons will have a fasting blood sample drawn and asked to randomly consume a 50g glucose drink (2 occasions), or 50g carbohydrate equivalent of cooked purple, red, yellow and white potatoes. Further blood samples will be obtained at 15,30, 45, 60, 90, 120, 180, 240 mins. Bloods from the first 2 hours will be analyzed for glucose and insulin to determine the glycemic response. Hourly blood samples will be analyzed for polyphenol to determine the bioavailability of polyphenols from the different potato variety. Urine samples will be collected before ingestion of the food items and again at 4 hours, and will be used to determine polyphenol bioavailability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose Standard | Active comparator | Other: Glycemic response to different varieties of potatoes |
| Potato Variety | Experimental | Other: Glycemic response to different varieties of potatoes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy, non-smoker on no medication
- normal glucose tolerance
- willing to have a catheter inserted in forearm
Key exclusion criteria (3 listed)
- abnormal glucose tolerance
- abnormal BMI
- on medication for a chronic disorder
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 |
|---|---|---|
| Glycemic response to different varieties of potatoesAlso: Purple potato, Red potato, White potato, Yellow potaotthe glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard | Other | Glucose Standard, Potato Variety |
Primary outcome
Glycemic response
Time frame: 2 hrs
1 secondary outcome
Bioavailability of polyphenols from potatoes
Time frame: 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 17 Jan 2011.
- Background: PubMed 18175765Wolever TM, Brand-Miller JC, Abernethy J, Astrup A, Atkinson F, Axelsen M, Bjorck I, Brighenti F, Brown R, Brynes A, Casiraghi MC, Cazaubiel M, Dahlqvist L, Delport E, Denyer GS, Erba D, Frost G, Granfeldt Y, Hampton S, Hart VA, Hatonen KA, Henry CJ, Hertzler S, Hull S, Jerling J, Johnston KL, Lightowler H, Mann N, Morgan L, Panlasigui LN, Pelkman C, Perry T, Pfeiffer AF, Pieters M, Ramdath DD, Ramsingh RT, Robert SD, Robinson C, Sarkkinen E, Scazzina F, Sison DC, Sloth B, Staniforth J, Tapola N, Valsta LM, Verkooijen I, Weickert MO, Weseler AR, Wilkie P, Zhang J. Measuring the glycemic index of foods: interlaboratory study. Am J Clin Nutr. 2008 Jan;87(1):247S-257S. doi: 10.1093/ajcn/87.1.247S.
- Background: PubMed 15182400Ramdath DD, Isaacs RL, Teelucksingh S, Wolever TM. Glycaemic index of selected staples commonly eaten in the Caribbean and the effects of boiling v. crushing. Br J Nutr. 2004 Jun;91(6):971-7. doi: 10.1079/bjn20041125.
- Background: PubMed 12627186Wolever TM, Vorster HH, Bjorck I, Brand-Miller J, Brighenti F, Mann JI, Ramdath DD, Granfeldt Y, Holt S, Perry TL, Venter C, Xiaomei Wu. Determination of the glycaemic index of foods: interlaboratory study. Eur J Clin Nutr. 2003 Mar;57(3):475-82. doi: 10.1038/sj.ejcn.1601551.
- Background: PubMed 12090025Wolever TM, Isaacs RL, Ramdath DD. Lower diet glycaemic index in African than South Asian men in Trinidad and Tobago. Int J Food Sci Nutr. 2002 Jul;53(4):297-303. doi: 10.1080/09637480220138142.
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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.
Dan Ramdath, PhD principal investigator
Agriculture and Agri-Food Canada
Maggie Laidlaw, PhD study director
Nutracource Diagnostics Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic response to different varieties of potatoes in people with Diabetes and Insulin Resistance, run by Guelph Food Research Centre 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 3 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 17 Jan 2011. 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. 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?
Glycemic response (time frame: 2 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053793, which also lists 4 linked publications.
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 17 Jan 2011.