Postprandial GlycemiaNCT02940080
Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
A study testing Dietary in people with Postprandial Glycemia, run by University of Turku at 1 site in Finland.
Trial summary
A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2016to 31 Dec 2021
- 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.
About this study
A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites, and the appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine and feces.
- Conditions
- Postprandial Glycemia
- Being tested
- Dietary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryOther
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanins and yellow potato | Experimental | 168 mg of anthocyanins extracted from purple-fleshed potatoes added to 350 g of steam-cooked mashed potatoes in water Receives: Other: Dietary |
| Yellow potato | Experimental | 350 g of steam-cooked mashed potatoes in water Receives: Other: Dietary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose concentration
Measured: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
Measured: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Secondary outcomes (5)
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements)
Measured: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements)
Measured: Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements)
Measured: before and after meal
Area under the glucose concentration curve (AUC)
Measured: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Area under the insulin concentration curve (AUC)
Measured: 0min, 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 posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- 18 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
- Investigators
- Kaisa M Linderborg, PhD, Principal investigator, Department of Biochemistry, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940080
- Sponsor's protocol ID
- Siniset perunat 2
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2016
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
- ClinicalTrials.gov ID
- NCT02940080
- Acronym / sponsor ID
- Siniset perunat 2
- Conditions
- Postprandial Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 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.
A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites, and the appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine and feces.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanins and yellow potato | Experimental | Other: Dietary168 mg of anthocyanins extracted from purple-fleshed potatoes added to 350 g of steam-cooked mashed potatoes in water |
| Yellow potato | Experimental | Other: Dietary350 g of steam-cooked mashed potatoes in water |
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 | Other | Anthocyanins and yellow potato, Yellow potato |
Primary outcome
Plasma glucose concentration
Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
5 secondary outcomes
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements)
Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements)
Time frame: Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h
Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements)
Time frame: before and after meal
Area under the glucose concentration curve (AUC)
Time frame: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Area under the insulin concentration curve (AUC)
Time frame: 0min, 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 14 Mar 2022.
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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.
Kaisa M Linderborg, PhD principal investigator
Department of Biochemistry, University of Turku
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 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 14 Mar 2022. 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: 0min, 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 14 Mar 2022.