Hyperglycemia, PostprandialNCT02743130
Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar
A study testing Blackcurrant Nectar, Lingonberry Nectar and Reference in people with Hyperglycemia, Postprandial, run by University of Eastern Finland at 1 site in Finland.
Trial summary
Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. Read more about this study
- Who is it for?
- Ages 25 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial
- What is being tested?
- Blackcurrant Nectar, Lingonberry Nectar and Reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to Nov 2014
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-28 kg/m2
- Normal fasting plasma glucose
Who cannot join
- Smoking
- Diabetes or other chronic disease
- Antibiotic medication within the past 3 months
- Blood donation within the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Glycemic Response to Berry Nectars Containing Inverted Sugar
Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.
- Conditions
- Hyperglycemia, Postprandial
- Being tested
- Blackcurrant Nectar, Lingonberry Nectar, Reference
- Keywords
- Berries, Blackcurrant (Ribes nigrum), Lingonberry (Vaccinium vitis-idaea), Sucrose, Inverted sugar, Postprandial glucose response, Postprandial insulin response
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackcurrant NectarDietary supplement
Consumption of a single dose (300 ml)
Lingonberry NectarDietary supplement
Consumption of a single dose (300 ml)
ReferenceDietary supplement
Consumption of a single dose (300 ml)
| Study group | Role | What they receive |
|---|---|---|
| Blackcurrant nectar | Experimental | Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose Receives: Dietary Supplement: Blackcurrant Nectar |
| Lingonberry nectar | Experimental | Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose Receives: Dietary Supplement: Lingonberry Nectar |
| Reference | Active comparator | Sugar control, contains 17.5 g glucose and 17.5 g fructose in water Receives: Dietary Supplement: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose response
0, 15, 30, 45, 60, 90, 120 minutes post-meal
Measured: 2 hours
Secondary outcomes (1)
Plasma insulin response
0, 15, 30, 45, 60, 90, 120 minutes post-meal
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, PostprandialStudies 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 Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Finnsugar Ltd
- Responsible party
- Principal investigator, Riitta Törrönen, University of Eastern Finland
- Investigators
- Riitta Törrönen, Dr, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743130
- Sponsor's protocol ID
- INVE 903/020502/2014
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycemic Response to Berry Nectars Containing Inverted Sugar
- ClinicalTrials.gov ID
- NCT02743130
- Acronym / sponsor ID
- INVE 903/020502/2014
- Conditions
- Hyperglycemia, Postprandial
- Keywords
- Berries, Blackcurrant (Ribes nigrum), Lingonberry (Vaccinium vitis-idaea), Sucrose, Inverted sugar, Postprandial glucose response, Postprandial insulin response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Finnsugar Ltd
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Apr 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.
Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blackcurrant nectar | Experimental | Dietary Supplement: Blackcurrant NectarContains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose |
| Lingonberry nectar | Experimental | Dietary Supplement: Lingonberry NectarContains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose |
| Reference | Active comparator | Dietary Supplement: ReferenceSugar control, contains 17.5 g glucose and 17.5 g fructose in water |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 20-28 kg/m2
- Normal fasting plasma glucose
Key exclusion criteria (4 listed)
- Smoking
- Diabetes or other chronic disease
- Antibiotic medication within the past 3 months
- Blood donation within the past month
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 |
|---|---|---|
| Blackcurrant NectarConsumption of a single dose (300 ml) | Dietary supplement | Blackcurrant nectar |
| Lingonberry NectarConsumption of a single dose (300 ml) | Dietary supplement | Lingonberry nectar |
| ReferenceConsumption of a single dose (300 ml) | Dietary supplement | Reference |
Primary outcome
Plasma glucose response
Time frame: 2 hours
0, 15, 30, 45, 60, 90, 120 minutes post-meal
1 secondary outcome
Plasma insulin response
Time frame: 2 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 19 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Riitta Törrönen, Dr principal investigator
Senior Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blackcurrant Nectar, Lingonberry Nectar and Reference in people with Hyperglycemia, Postprandial, 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 2 inclusion and 4 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 19 Apr 2016. 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 response (time frame: 2 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 19 Apr 2016.