- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414647
The Health Effect of Diet Rich in Nordic Berries (Berry)
The Effect of Diet Rich in Nordic Berries on Gut Microbiota, Glucose and Lipid Metabolism and Metabolism on Fenolic Compounds
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kuopio, Finland, FIN-70211
- University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- chronic diseases
- use of lipid lowering medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SRC
Strawberry, raspberry and cloudberry intervention for 8 weeks
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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.
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Experimental: BB
Bilberry intervention for 8 weeks
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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.
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Experimental: C
Control diet with restricted berry consumption
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Control diet, ie.
habitual diet with restriction of berry consumption was consumed for eight weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose level
Time Frame: week 8
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Fasting glucose level oral glucose tolerance status at study week 8
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week 8
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Cholesterol level
Time Frame: week 8
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total, HDL and LDL cholesterol level at the study week 8
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week 8
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Inflammation markers
Time Frame: week 8
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Various inflammation markers were measured at the study week 8
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week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Markers of sterol metabolism
Time Frame: week 8
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Markers of cholesterol absorption and synthesis were measured
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week 8
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gene expression in PBMCs
Time Frame: study week 8
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Global gene expression analyses in peripheral mononuclear cells (PBMC)
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study week 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Riitta Törrönen, Adjunct Professor, University of Eastern Finland
Publications and helpful links
General 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.
- Kolehmainen 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 124//2005
- 40361/05 (Other Grant/Funding Number: Tekes, National Technology Agency of Finland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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