Metabolic SyndromeBerryNCT01414647
The Health Effect of Diet Rich in Nordic Berries
A study testing 300 g of strawberry, raspberry and cloudberry and 400 g of bilberry in people with Metabolic Syndrome and Impaired Glucose Tolerance, run by Marjukka Kolehmainen at 1 site in Finland.
Trial summary
Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on the studies made in animals or cell cultures. The findings regarding the possible decrease of low-grade inflammation are existing also in humans. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Impaired Glucose Tolerance, Low-grade Inflammation
- What is being tested?
- 300 g of strawberry, raspberry and cloudberry and 400 g of bilberry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2006to Mar 2010
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight (BMI 26-39 kg/m2), and two of the following:
- elevated fasting plasma glucose in the absence of diabetes (5.6-6.9 mmol/l)
- abnormal serum lipid concentration: fasting serum triglyceride concentration >1.7 mmol/L, fasting serum HDL cholesterol <1.0 mmol/L (males) or <1.3 mmol/L (females))
- waist circumference >102 cm (males) or >88 cm (females)
- blood pressure >130/85 mmHg
Who cannot join
- chronic diseases
- use of lipid lowering medication
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
Kuopio, FIN-70211
About this study
Official title: The Effect of Diet Rich in Nordic Berries on Gut Microbiota, Glucose and Lipid Metabolism and Metabolism on Fenolic Compounds
Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on the studies made in animals or cell cultures. The findings regarding the possible decrease of low-grade inflammation are existing also in humans. Low-grade inflammation has been suggested to be a mechanistic link between obesity and its consequences on cardiometabolic health. The aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers.
Read the detailed description
Berries are traditionally an important part of the Nordic diet. About 50 different berries are grown in the northern region, and about half of them are edible. Phenolic compounds are one of the most diverse group of secondary metabolites present in edible plants, and berries are especially rich in them. Flavonoids, phenolic acids, lignans and complex phenolic polymers (polymeric tannins) are typical for berries. Phenolic compounds are reported to have a variety of beneficial biological properties. They are potent antioxidants, and exhibit various other physiological activities including anti-inflammatory, antimicrobial, antiallergic, anticarcinogenic and antihypertensive activities. Epidemiological studies indicate that diet rich in phenolic compound correlates with lower risk of cancer and cardiovascular disease.
The aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers and gene expression profile in peripheral blood mononuclear cells (PBMCs) in subjects with features of metabolic syndrome.
Randomized, controlled clinical intervention including 4 wk run-in period, 8 wk dietary intervention and 4 wk recovery period was conducted.
- Being tested
- 300 g of strawberry, raspberry and cloudberry, 400 g of bilberry, Control diet
- Keywords
- Bilberry, Vaccinium myrtillus, Metabolic syndrome, Glucose metabolism, Lipid metabolism, Inflammation, Gene expression
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 g of strawberry, raspberry and cloudberryDietary supplement
100 g of strawberry puree, 100 g of frozen raspberries and 100 g frozen cloudberries were concumed daily for 8 weeks. Bilberry consumption was restricted.
400 g of bilberryDietary supplement
Equivalent amount to 400 g of fresh bilberries were consumed as 40 g of dried bilberries and as 200 g of frozen bilberries. Restriction of use of strawberries, raspberries and cloudberries were set.
Control dietOther
Also called Diet with restricted consumption of berries.
Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| SRC | Experimental | Strawberry, raspberry and cloudberry intervention for 8 weeks Receives: Dietary Supplement: 300 g of strawberry, raspberry and cloudberry |
| BB | Experimental | Bilberry intervention for 8 weeks Receives: Dietary Supplement: 400 g of bilberry |
| C | Experimental | Control diet with restricted berry consumption Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
Fasting glucose level oral glucose tolerance status at study week 8
Measured: week 8
Cholesterol level
total, HDL and LDL cholesterol level at the study week 8
Measured: week 8
Inflammation markers
Various inflammation markers were measured at the study week 8
Measured: week 8
Secondary outcomes (2)
Markers of sterol metabolism
Markers of cholesterol absorption and synthesis were measured
Measured: week 8
gene expression in PBMCs
Global gene expression analyses in peripheral mononuclear cells (PBMC)
Measured: study week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionMar 2010
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 Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marjukka Kolehmainen
- Sponsor type
- University, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland
- Responsible party
- Sponsor-investigator, Marjukka Kolehmainen, University of Eastern Finland
- Investigators
- Riitta Törrönen, Adjunct Professor, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414647
- Sponsor's protocol ID
- 124//2005
- Other IDs
- 40361/05
- Acronym
- Berry
- Status last verified
- May 2018
- First submitted
- 10 Aug 2011
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puupponen-Pimia R, Seppanen-Laakso T, Kankainen M, Maukonen J, Torronen R, Kolehmainen M, Leppanen T, Moilanen E, Nohynek L, Aura AM, Poutanen K, Tomas-Barberan FA, Espin JC, Oksman-Caldentey KM. Effects of ellagitannin-rich berries on blood lipids, gut microbiota, and urolithin production in human subjects with symptoms of metabolic syndrome. Mol Nutr Food Res. 2013 Dec;57(12):2258-63. doi: 10.1002/mnfr.201300280. Epub 2013 Aug 12.
PubMed 23934737Kolehmainen M, Mykkanen O, Kirjavainen PV, Leppanen T, Moilanen E, Adriaens M, Laaksonen DE, Hallikainen M, Puupponen-Pimia R, Pulkkinen L, Mykkanen H, Gylling H, Poutanen K, Torronen R. Bilberries reduce low-grade inflammation in individuals with features of metabolic syndrome. Mol Nutr Food Res. 2012 Oct;56(10):1501-10. doi: 10.1002/mnfr.201200195. Epub 2012 Sep 7.
PubMed 22961907
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diet Rich in Nordic Berries on Gut Microbiota, Glucose and Lipid Metabolism and Metabolism on Fenolic Compounds
- ClinicalTrials.gov ID
- NCT01414647
- Acronym / sponsor ID
- Berry / 124//2005
- Keywords
- Bilberry, Vaccinium myrtillus, Metabolic syndrome, Glucose metabolism, Lipid metabolism, Inflammation, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Marjukka KolehmainenUniversity, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Aug 2011 (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.
Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on the studies made in animals or cell cultures. The findings regarding the possible decrease of low-grade inflammation are existing also in humans. Low-grade inflammation has been suggested to be a mechanistic link between obesity and its consequences on cardiometabolic health. The aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers.
Detailed description
Berries are traditionally an important part of the Nordic diet. About 50 different berries are grown in the northern region, and about half of them are edible. Phenolic compounds are one of the most diverse group of secondary metabolites present in edible plants, and berries are especially rich in them. Flavonoids, phenolic acids, lignans and complex phenolic polymers (polymeric tannins) are typical for berries. Phenolic compounds are reported to have a variety of beneficial biological properties. They are potent antioxidants, and exhibit various other physiological activities including anti-inflammatory, antimicrobial, antiallergic, anticarcinogenic and antihypertensive activities. Epidemiological studies indicate that diet rich in phenolic compound correlates with lower risk of cancer and cardiovascular disease.
The aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers and gene expression profile in peripheral blood mononuclear cells (PBMCs) in subjects with features of metabolic syndrome.
Randomized, controlled clinical intervention including 4 wk run-in period, 8 wk dietary intervention and 4 wk recovery period was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SRC | Experimental | Dietary Supplement: 300 g of strawberry, raspberry and cloudberryStrawberry, raspberry and cloudberry intervention for 8 weeks |
| BB | Experimental | Dietary Supplement: 400 g of bilberryBilberry intervention for 8 weeks |
| C | Experimental | Other: Control dietControl diet with restricted berry consumption |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- overweight (BMI 26-39 kg/m2), and two of the following:
- elevated fasting plasma glucose in the absence of diabetes (5.6-6.9 mmol/l)
- abnormal serum lipid concentration: fasting serum triglyceride concentration >1.7 mmol/L, fasting serum HDL cholesterol <1.0 mmol/L (males) or <1.3 mmol/L (females))
- waist circumference >102 cm (males) or >88 cm (females)
- blood pressure >130/85 mmHg
Key exclusion criteria (2 listed)
- chronic diseases
- use of lipid lowering medication
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 |
|---|---|---|
| 300 g of strawberry, raspberry and cloudberry100 g of strawberry puree, 100 g of frozen raspberries and 100 g frozen cloudberries were concumed daily for 8 weeks. Bilberry consumption was restricted. | Dietary supplement | SRC |
| 400 g of bilberryEquivalent amount to 400 g of fresh bilberries were consumed as 40 g of dried bilberries and as 200 g of frozen bilberries. Restriction of use of strawberries, raspberries and cloudberries were set. | Dietary supplement | BB |
| Control dietAlso: Diet with restricted consumption of berries.Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks | Other | C |
Primary outcome
Glucose level
Time frame: week 8
Fasting glucose level oral glucose tolerance status at study week 8
Cholesterol level
Time frame: week 8
total, HDL and LDL cholesterol level at the study week 8
Inflammation markers
Time frame: week 8
Various inflammation markers were measured at the study week 8
2 secondary outcomes
Markers of sterol metabolism
Time frame: week 8
gene expression in PBMCs
Time frame: study week 8
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 17 May 2018.
- Derived from this study: PubMed 23934737Puupponen-Pimia R, Seppanen-Laakso T, Kankainen M, Maukonen J, Torronen R, Kolehmainen M, Leppanen T, Moilanen E, Nohynek L, Aura AM, Poutanen K, Tomas-Barberan FA, Espin JC, Oksman-Caldentey KM. Effects of ellagitannin-rich berries on blood lipids, gut microbiota, and urolithin production in human subjects with symptoms of metabolic syndrome. Mol Nutr Food Res. 2013 Dec;57(12):2258-63. doi: 10.1002/mnfr.201300280. Epub 2013 Aug 12.
- Derived from this study: PubMed 22961907Kolehmainen M, Mykkanen O, Kirjavainen PV, Leppanen T, Moilanen E, Adriaens M, Laaksonen DE, Hallikainen M, Puupponen-Pimia R, Pulkkinen L, Mykkanen H, Gylling H, Poutanen K, Torronen R. Bilberries reduce low-grade inflammation in individuals with features of metabolic syndrome. Mol Nutr Food Res. 2012 Oct;56(10):1501-10. doi: 10.1002/mnfr.201200195. Epub 2012 Sep 7.
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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, Adjunct Professor principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 g of strawberry, raspberry and cloudberry and 400 g of bilberry in people with Metabolic Syndrome and Impaired Glucose Tolerance, 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 5 inclusion and 2 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 17 May 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 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?
Glucose level (time frame: week 8). The study lists 3 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 NCT01414647, 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 17 May 2018.