HealthyNCT01575509
A Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects
A study testing Berry product and Bread product in people with Healthy, run by Clinical Life Sciences Ltd. at 1 site in Finland.
Trial summary
This study aims to determine the 2 hour glycemic responses of two bread products and one dried lingonberry product. The average postprandial response of each product is compared with glycemic response after ingestion of control solution with a similar carbohydrate content (glucose, glucose-fructose) as the provided by… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Berry product and Bread product
- How many people
- 14 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Jun 2012
- 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
- voluntary given written concent for participation in research
- healthy man or woman, age between 18 and 65 years
- regular eating
- Body Mass Index 18,5 - 29,9 kg/m2
Who cannot join
- diabetes
- gastrointestinal diseases
- hepatic, kidney, pancreas or thyroid disease or disorder
- arthritis
- pregnancy or breast feeding
- smoking
Show all 9Show fewer
- allergy
- severe diseases
- blood donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical, Randomized, Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects
This study aims to determine the 2 hour glycemic responses of two bread products and one dried lingonberry product. The average postprandial response of each product is compared with glycemic response after ingestion of control solution with a similar carbohydrate content (glucose, glucose-fructose) as the provided by the respective test product.
- Conditions
- Healthy
- Being tested
- Berry product, Bread product, Glucose control solution, Glucose-fructose control solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry productOther
Sugar infused dried lingonberry
Bread productOther
Brown bread
Bread productOther
Whole grain bread
Glucose control solutionOther
Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products
Glucose-fructose control solutionOther
Control solution with a similar carbohydrate content as provided by the dried lingonberry test product
What is being measured
The primary outcome is the main question the study is designed to answer.
The 2 hours glycemic responses to test products and control solutions
Capillary blood samples are taken before and at 15, 30, 45, 60, 90 and 120 min after starting to eat the test products or control solutions for measurements of plasma glucose concentrations.
Measured: 2 hours
Secondary outcomes (3)
The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution
Capillary blood samples are collected before and at 15, 30, 45, 60, 90 and 120 min after eating the lingonberry test product and glucose-fructose control solution. The serum insulin concentrations are analysed.
Measured: 2 hours
The incremental area under glucose curve (IAUC) of bread test products
IAUC (mmol/l x min) is determined using the trapezoidal method for each subject and bread test product and corresponding glucose control solution.
Measured: 2 hours
Glycemic index (GI) of bread test products
The GI is calculated as a percentage of the glucose IAUC values of a bread product and a glucose control solution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Life Sciences Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Kiantama Oy, Suomen Sokeri Oy
- Responsible party
- Sponsor
- Investigators
- Päivi Cheney, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575509
- Sponsor's protocol ID
- MAVI
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Randomized, Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01575509
- Acronym / sponsor ID
- MAVI
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Clinical Life Sciences Ltd.University, hospital or other
- Collaborators
- Kiantama Oy, Suomen Sokeri Oy
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Apr 2012 (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.
This study aims to determine the 2 hour glycemic responses of two bread products and one dried lingonberry product. The average postprandial response of each product is compared with glycemic response after ingestion of control solution with a similar carbohydrate content (glucose, glucose-fructose) as the provided by the respective test product.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- voluntary given written concent for participation in research
- healthy man or woman, age between 18 and 65 years
- regular eating
- Body Mass Index 18,5 - 29,9 kg/m2
Key exclusion criteria (9 listed)
- diabetes
- gastrointestinal diseases
- hepatic, kidney, pancreas or thyroid disease or disorder
- arthritis
- pregnancy or breast feeding
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 |
|---|---|---|
| Berry productSugar infused dried lingonberry | Other | – |
| Bread productBrown bread | Other | – |
| Bread productWhole grain bread | Other | – |
| Glucose control solutionGlucose solution with a corresponding amount of carbohydrates as provided by the bread test products | Other | – |
| Glucose-fructose control solutionControl solution with a similar carbohydrate content as provided by the dried lingonberry test product | Other | – |
Primary outcome
The 2 hours glycemic responses to test products and control solutions
Time frame: 2 hours
Capillary blood samples are taken before and at 15, 30, 45, 60, 90 and 120 min after starting to eat the test products or control solutions for measurements of plasma glucose concentrations.
3 secondary outcomes
The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution
Time frame: 2 hours
The incremental area under glucose curve (IAUC) of bread test products
Time frame: 2 hours
Glycemic index (GI) of bread test products
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 15 Jun 2012.
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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.
Päivi Cheney, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry product and Bread product in people with Healthy, run by Clinical Life Sciences Ltd. 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 4 inclusion and 9 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 15 Jun 2012. 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?
The 2 hours glycemic responses to test products and control solutions (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 15 Jun 2012.