Postprandial HyperglycemiaNCT03159065
Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance
A study testing Bilberry, Blackcurrant and Mango in people with Postprandial Hyperglycemia, run by Lund University.
Trial summary
Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being. It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Bilberry, Blackcurrant and Mango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, not on medication, non-allergic, individuals aged 18-65 years old, having a BMI between 20-30 kg/m2 and also maintaining stable body weight, i.e. less than 5% weight change in the last three months before the study.
Who cannot join
- -
About this study
Official title: Early Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance in Healthy Adults
Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being. It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand. In the present study, the impact of probiotic fruit beverages with different polyphenol profiles on the postprandial levels of glucose and insulin, were investigated.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Bilberry, Blackcurrant, Mango, Beetroot, Rose hip
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilberryOther
Fruit beverage with bilberry and fermented oatmeal
BlackcurrantOther
Fruit beverage with blackcurrant and fermented oatmeal
MangoOther
Fruit beverage with mango and fermented oatmeal
BeetrootOther
Fruit beverage with beetroot and fermented oatmeal
Rose hipOther
Fruit beverage with rose hip and fermented oatmeal
Glucose drinkOther
A reference glucose drink
| Study group | Role | What they receive |
|---|---|---|
| Bilberry | Experimental | A bilberry-based beverage with fermented oatmeal Receives: Other: Bilberry |
| Blackcurrant | Experimental | A blackcurrant-based beverage with fermented oatmeal Receives: Other: Blackcurrant |
| Mango | Experimental | A mango-based based beverage with fermented oatmeal Receives: Other: Mango |
| Beetroot | Experimental | A beetroot-based based beverage with fermented oatmeal Receives: Other: Beetroot |
| Rose hip | Experimental | A rose hip-based based beverage with fermented oatmeal Receives: Other: Rose hip |
| Glucose drink | Active comparator | A reference glucose drink Receives: Other: Glucose drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the study products on the postprandial serum insulin
The postprandial incremental area under the curve for serum insulin
Measured: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
Secondary outcomes (1)
Efficacy of the study products on the postprandial serum glucose
The postprandial incremental area under the curve for serum glucose
Measured: Incremental area under the curve for serum glucose 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 posted18 May 2017
- Study startSep 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial HyperglycemiaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
- Investigators
- Yvonne Granfeldt, Prof, Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159065
- Sponsor's protocol ID
- InVeg (1)
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Jonsson T, Plaza M, Hakansson A, Antonsson M, Ahren IL, Turner C, Spegel P, Granfeldt Y. Probiotic fruit beverages with different polyphenol profiles attenuated early insulin response. Nutr J. 2018 Feb 27;17(1):34. doi: 10.1186/s12937-018-0335-0.
PubMed 29486772
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance in Healthy Adults
- ClinicalTrials.gov ID
- NCT03159065
- Acronym / sponsor ID
- InVeg (1)
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 May 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.
Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being. It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand. In the present study, the impact of probiotic fruit beverages with different polyphenol profiles on the postprandial levels of glucose and insulin, were investigated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bilberry | Experimental | Other: BilberryA bilberry-based beverage with fermented oatmeal |
| Blackcurrant | Experimental | Other: BlackcurrantA blackcurrant-based beverage with fermented oatmeal |
| Mango | Experimental | Other: MangoA mango-based based beverage with fermented oatmeal |
| Beetroot | Experimental | Other: BeetrootA beetroot-based based beverage with fermented oatmeal |
| Rose hip | Experimental | Other: Rose hipA rose hip-based based beverage with fermented oatmeal |
| Glucose drink | Active comparator | Other: Glucose drinkA reference glucose drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, not on medication, non-allergic, individuals aged 18-65 years old, having a BMI between 20-30 kg/m2 and also maintaining stable body weight, i.e. less than 5% weight change in the last three months before the study.
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 |
|---|---|---|
| BilberryFruit beverage with bilberry and fermented oatmeal | Other | Bilberry |
| BlackcurrantFruit beverage with blackcurrant and fermented oatmeal | Other | Blackcurrant |
| MangoFruit beverage with mango and fermented oatmeal | Other | Mango |
| BeetrootFruit beverage with beetroot and fermented oatmeal | Other | Beetroot |
| Rose hipFruit beverage with rose hip and fermented oatmeal | Other | Rose hip |
| Glucose drinkA reference glucose drink | Other | Glucose drink |
Primary outcome
Efficacy of the study products on the postprandial 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 postprandial incremental area under the curve for serum insulin
1 secondary outcome
Efficacy of the study products on the postprandial serum glucose
Time frame: Incremental area under the curve for serum glucose from 0 min up to 120 min following the ingestion of the study product
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 May 2017.
- Derived from this study: PubMed 29486772Xu J, Jonsson T, Plaza M, Hakansson A, Antonsson M, Ahren IL, Turner C, Spegel P, Granfeldt Y. Probiotic fruit beverages with different polyphenol profiles attenuated early insulin response. Nutr J. 2018 Feb 27;17(1):34. doi: 10.1186/s12937-018-0335-0.
- 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.
Yvonne Granfeldt, Prof study director
Lund University
Questions about this trial
What is this clinical trial studying?
A study testing Bilberry, Blackcurrant and Mango in people with Postprandial Hyperglycemia, run by Lund University.
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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Efficacy of the study products on the postprandial 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?
On the ClinicalTrials.gov record for NCT03159065, which also lists 1 linked publication.
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 May 2017.