Postprandial GlycemiaNCT02005796
Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries
A study testing Dietary intervention in people with Postprandial Glycemia, run by University of Turku at 1 site in Finland.
Trial summary
In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemia
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2013to May 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45
- Male
- No regular medication
- No participation in a drug trial or blood donation within 2 months
- Non-smoker
- Signs informed consent
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- Body mass index 18.5-27 kg/m2
- Fasting plasma cholesterol < 5.5 mmol/l
- Fasting plasma triacylglycerols < 2.6 mmol/l
- Fasting plasma glucose 4-6 mmol/l
- blood pressure <140/80 mmHg
- hemoglobin>130 g/l
- Fasting plasma alanine amino transferase (ALAT) <60 U/l (normal liver function)
- Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
- Fasting plasma creatinine <118 µmol/l (normal kidney function)
Who cannot join
- Regular smoking
- Alcohol abuse
- Regular medication
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Biochemistry, University of Turku
University of Turku, Turku, 20014
About this study
In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.
- Conditions
- Postprandial Glycemia
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Blue-fleshed potato tubers | Experimental | Intervention: Steam cooked mashed potato tubers Receives: Other: Dietary intervention |
| Yellow-fleshed potato tubers | Experimental | Intervention: Steam cooked mashed potato tubers Receives: Other: Dietary intervention |
| Bilberries and potato starch | Experimental | Intervention: A gel boiled with bilberries and potato starch Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose concentration
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary outcomes (2)
Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (HPLC-measurement)
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (NMR-measurement)
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial GlycemiaStudies 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
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaisa Linderborg, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005796
- Sponsor's protocol ID
- Siniset perunat
- Status last verified
- May 2015
- First submitted
- 3 Dec 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries
- ClinicalTrials.gov ID
- NCT02005796
- Acronym / sponsor ID
- Siniset perunat
- Conditions
- Postprandial Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Dec 2013 (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.
In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blue-fleshed potato tubers | Experimental | Other: Dietary interventionIntervention: Steam cooked mashed potato tubers |
| Yellow-fleshed potato tubers | Experimental | Other: Dietary interventionIntervention: Steam cooked mashed potato tubers |
| Bilberries and potato starch | Experimental | Other: Dietary interventionIntervention: A gel boiled with bilberries and potato starch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age 18-45
- Male
- No regular medication
- No participation in a drug trial or blood donation within 2 months
- Non-smoker
Key exclusion criteria (3 listed)
- Regular smoking
- Alcohol abuse
- Regular medication
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 |
|---|---|---|
| Dietary intervention | Other | Bilberries and potato starch, Blue-fleshed potato tubers, Yellow-fleshed potato tubers |
Primary outcome
Plasma glucose concentration
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
2 secondary outcomes
Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (HPLC-measurement)
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (NMR-measurement)
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
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 20 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Postprandial Glycemia, run by University of Turku at 1 site in Finland.
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 15 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 20 May 2015. 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 Finland. 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?
Plasma glucose concentration (time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min). 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 20 May 2015.