Postprandial HyperglycemiaMAQUANCT04150926
The Effect of Black Currant on Postprandial Glucose Metabolism
A study testing Black currant, Black currant-quinoa product and Quinoa base in people with Postprandial Hyperglycemia and Prediabetic State, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Prediabetic State
- What is being tested?
- Black currant, Black currant-quinoa product and Quinoa base
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 15 Aug 2019to 30 Apr 2020
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: 25-65 years
- BMI: 20-28 kg/m2
- Perceived health status: Good
Who cannot join
- fasting glucose: > 7.0 mmol/l
- LDL-cholesterol: > 3.0 mmol/l
- total cholesterol: > 6.5 mmol/l
- blood pressure : > 160/100 mmHg
- weight change of > 5% during previous 6 months or active weightreduction
- no serious chronic diseases
- one exception of the exclusion criteria maybe accepted after the MD consideration
Trial locations and contacts
1 site in 1 country.
About this study
The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.
Read the detailed description
The study examines the effect of black currant on glucose and insulin concentrations after a meal.
Healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the research laboratory, when four meals are served in randomised order. Meals are: black currant puree, black currant and quinoa based snack, quinoa base and liquid containing glucose, fructose and sucrose. The meals contain the same amount of carbohydrates.
In addition to glucose and insulin concentration, cytokine and free fatty acid concentrations are measured after each meal.
- Conditions
- Postprandial Hyperglycemia, Prediabetic State
- Being tested
- Black currant, Black currant-quinoa product, Quinoa base
- Keywords
- berries, black currant, glucose, glycemia, quinoa
- Medical subject headings
- Hyperglycemia, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black currantOther
The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose
Experimental: Black currant and quinoa product
Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base
Black currant-quinoa productOther
The effect of black currant puree will be compared with black currant-quinoa product
Quinoa baseOther
The effect of black currant puree will be compared with quinoa base
| Study group | Role | What they receive |
|---|---|---|
| Black currant puree | Experimental | Black currant puree Receives: Other: Black currant |
| Black currant-quinoa product | Active comparator | Black currant-quinoa product Receives: Other: Black currant-quinoa product |
| Quinoa base | Active comparator | Quinoa base is used for the black currant-quinoa product. Receives: Other: Quinoa base |
| Liquid with glucose, fructose and sucrose | No intervention | Liquid with glucose, fructose and sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration
Glucose concentration after meal
Measured: 0 minutes until 180 minutes
Insulin concentration
Insulin concentration after meal
Measured: 0 minutes until 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Aug 2019
- Primary completion28 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Meal studies in randomised order
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Savonia University of Applied Sciences, Regional Development Company SavoGrow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150926
- Sponsor's protocol ID
- 894/2019
- Acronym
- MAQUA
- Status last verified
- Sep 2020
- First submitted
- 1 Nov 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data maybe shared in the future.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Black Currant on Postprandial Glucose Metabolism
- ClinicalTrials.gov ID
- NCT04150926
- Acronym / sponsor ID
- MAQUA / 894/2019
- Conditions
- Postprandial Hyperglycemia, Prediabetic State
- Keywords
- berries, black currant, glucose, glycemia, quinoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Savonia University of Applied Sciences, Regional Development Company SavoGrow
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Nov 2019 (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.
The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.
Detailed description
The study examines the effect of black currant on glucose and insulin concentrations after a meal.
Healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the research laboratory, when four meals are served in randomised order. Meals are: black currant puree, black currant and quinoa based snack, quinoa base and liquid containing glucose, fructose and sucrose. The meals contain the same amount of carbohydrates.
In addition to glucose and insulin concentration, cytokine and free fatty acid concentrations are measured after each meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Meal studies in randomised order
| Arm | Type | Receives |
|---|---|---|
| Black currant puree | Experimental | Other: Black currantBlack currant puree |
| Black currant-quinoa product | Active comparator | Other: Black currant-quinoa productBlack currant-quinoa product |
| Quinoa base | Active comparator | Other: Quinoa baseQuinoa base is used for the black currant-quinoa product. |
| Liquid with glucose, fructose and sucrose | No intervention | –Liquid with glucose, fructose and sucrose |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: 25-65 years
- BMI: 20-28 kg/m2
- Perceived health status: Good
Key exclusion criteria (7 listed)
- fasting glucose: > 7.0 mmol/l
- LDL-cholesterol: > 3.0 mmol/l
- total cholesterol: > 6.5 mmol/l
- blood pressure : > 160/100 mmHg
- weight change of > 5% during previous 6 months or active weightreduction
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 |
|---|---|---|
| Black currantThe effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose Experimental: Black currant and quinoa product Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base | Other | Black currant puree |
| Black currant-quinoa productThe effect of black currant puree will be compared with black currant-quinoa product | Other | Black currant-quinoa product |
| Quinoa baseThe effect of black currant puree will be compared with quinoa base | Other | Quinoa base |
Primary outcome
Glucose concentration
Time frame: 0 minutes until 180 minutes
Glucose concentration after meal
Insulin concentration
Time frame: 0 minutes until 180 minutes
Insulin concentration after meal
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 4 Sep 2020.
- Individual participant dataSharing planned: No. Anonymised data maybe shared in the future.
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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 Black currant, Black currant-quinoa product and Quinoa base in people with Postprandial Hyperglycemia and Prediabetic State, run by University of Eastern Finland 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 3 inclusion and 7 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 4 Sep 2020. 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?
Glucose concentration (time frame: 0 minutes until 180 minutes). 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 4 Sep 2020.