Blood Glucose, PostprandialSOMANCT01580150
Effects of Berries on Post-meal Blood Sugar
A study testing Berries and No berries in people with Blood Glucose, Postprandial and Blood Insulin, Postprandial, run by Marjukka Kolehmainen at 1 site in Finland.
Trial summary
The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose. Read more about this study
- Who is it for?
- Ages 25 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Postprandial, Blood Insulin, Postprandial, Hyperglycemia
- What is being tested?
- Berries and No berries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2009to Jan 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 25 to 69 years
- 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: Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch
The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.
Read the detailed description
Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.
The purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:
- Studies 1-2: white wheat bread (starch) is consumed with several berry species
- Study 3: white wheat bread or rye bread is consumed with a mixture of berries
- Study 4: sugar (sucrose) is consumed with berries and berry nectars
- Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.
- Being tested
- Berries, No berries
- Keywords
- Berries, Starch, Sucrose, Glucose, Insulin, Postprandial
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerriesOther
Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).
No berriesOther
Meals containing starch (bread) or sucrose are consumed without berries.
| Study group | Role | What they receive |
|---|---|---|
| Berry meal | Experimental | Carbohydrate meals with berries Receives: Other: Berries |
| Reference meal | Active comparator | Carbohydrate meals without berries Receives: Other: No berries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Measured: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
Plasma insulin
Measured: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
Secondary outcomes (1)
Plasma free fatty acids
Measured: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startNov 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marjukka Kolehmainen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marjukka Kolehmainen, University of Eastern Finland
- Investigators
- Riitta Törrönen, Dr, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580150
- Sponsor's protocol ID
- 247032
- Other IDs
- 70035/09, 1087/31/2009
- Acronym
- SOMA
- Status last verified
- Apr 2012
- First submitted
- 16 Apr 2012
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Torronen R, Kolehmainen M, Sarkkinen E, Poutanen K, Mykkanen H, Niskanen L. Berries reduce postprandial insulin responses to wheat and rye breads in healthy women. J Nutr. 2013 Apr;143(4):430-6. doi: 10.3945/jn.112.169771. Epub 2013 Jan 30.
PubMed 23365108Torronen R, Kolehmainen M, Sarkkinen E, Mykkanen H, Niskanen L. Postprandial glucose, insulin, and free fatty acid responses to sucrose consumed with blackcurrants and lingonberries in healthy women. Am J Clin Nutr. 2012 Sep;96(3):527-33. doi: 10.3945/ajcn.112.042184. Epub 2012 Aug 1.
PubMed 22854401
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch
- ClinicalTrials.gov ID
- NCT01580150
- Acronym / sponsor ID
- SOMA / 247032
- Keywords
- Berries, Starch, Sucrose, Glucose, Insulin, Postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marjukka KolehmainenUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 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.
The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.
Detailed description
Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.
The purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:
- Studies 1-2: white wheat bread (starch) is consumed with several berry species
- Study 3: white wheat bread or rye bread is consumed with a mixture of berries
- Study 4: sugar (sucrose) is consumed with berries and berry nectars
- Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berry meal | Experimental | Other: BerriesCarbohydrate meals with berries |
| Reference meal | Active comparator | Other: No berriesCarbohydrate meals without berries |
Who may qualify
- Ages
- 25 to 69 years
- 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 |
|---|---|---|
| BerriesMeals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL). | Other | Berry meal |
| No berriesMeals containing starch (bread) or sucrose are consumed without berries. | Other | Reference meal |
Primary outcome
Plasma glucose
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
Plasma insulin
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal
1 secondary outcome
Plasma free fatty acids
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes post-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 18 Apr 2012.
- Derived from this study: PubMed 23365108Torronen R, Kolehmainen M, Sarkkinen E, Poutanen K, Mykkanen H, Niskanen L. Berries reduce postprandial insulin responses to wheat and rye breads in healthy women. J Nutr. 2013 Apr;143(4):430-6. doi: 10.3945/jn.112.169771. Epub 2013 Jan 30.
- Derived from this study: PubMed 22854401Torronen R, Kolehmainen M, Sarkkinen E, Mykkanen H, Niskanen L. Postprandial glucose, insulin, and free fatty acid responses to sucrose consumed with blackcurrants and lingonberries in healthy women. Am J Clin Nutr. 2012 Sep;96(3):527-33. doi: 10.3945/ajcn.112.042184. Epub 2012 Aug 1.
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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 Berries and No berries in people with Blood Glucose, Postprandial and Blood Insulin, Postprandial, run by Marjukka Kolehmainen 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 18 Apr 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?
Plasma glucose (time frame: 0, 15, 30, 45, 60, 90, 120 minutes post-meal). 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?
On the ClinicalTrials.gov record for NCT01580150, which also lists 2 linked publications.
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 18 Apr 2012.