Insulin ResistanceNCT03185676
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
A study testing Bilberry and beverage without bilberries or probiotics in people with Insulin Resistance, run by Lund University at 1 site in Sweden.
Trial summary
The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Bilberry and beverage without bilberries or probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2017to 30 Nov 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adults with a BMI between 20-30
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder
Lund
About this study
Official title: The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.
The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.
- Conditions
- Insulin Resistance
- Being tested
- Bilberry, beverage without bilberries or probiotics
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilberryOther
A bilberry based probiotic beverage
beverage without bilberries or probioticsOther
A control beverage without bilberries or probiotics
| Study group | Role | What they receive |
|---|---|---|
| Billberry | Experimental | A bilberry-based probiotic beverage Receives: Other: Bilberry |
| Control | Active comparator | A control beverage without bilberries or probiotics Receives: Other: beverage without bilberries or probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
The incremental area under the curve (AUC) will be measured for the levels of postprandial serum insuling from 0 min to 120 min following ingestion of the product (included intermediate measuring time points are 30, 60 and 90 min)
Measured: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start2 May 2017
- Primary completion15 Jul 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185676
- Sponsor's protocol ID
- InVeg (2)
- Status last verified
- Feb 2018
- First submitted
- 12 Jun 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.
- ClinicalTrials.gov ID
- NCT03185676
- Acronym / sponsor ID
- InVeg (2)
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 14 Jun 2017 (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 impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billberry | Experimental | Other: BilberryA bilberry-based probiotic beverage |
| Control | Active comparator | Other: beverage without bilberries or probioticsA control beverage without bilberries or probiotics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults with a BMI between 20-30
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BilberryA bilberry based probiotic beverage | Other | Billberry |
| beverage without bilberries or probioticsA control beverage without bilberries or probiotics | Other | Control |
Primary outcome
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
Time frame: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
The incremental area under the curve (AUC) will be measured for the levels of postprandial serum insuling from 0 min to 120 min following ingestion of the product (included intermediate measuring time points are 30, 60 and 90 min)
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 8 Feb 2018.
- 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.
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 Bilberry and beverage without bilberries or probiotics in people with Insulin Resistance, run by Lund University at 1 site in Sweden.
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 1 inclusion and 1 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 8 Feb 2018. 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 Sweden. 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?
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin (time frame: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product). 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 8 Feb 2018.