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The Health Effect of Diet Rich in Nordic Berries (Berry)

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ClinicalTrials.gov Identifier: NCT01414647
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Metabolic Syndrome Impaired Glucose Tolerance Low-grade Inflammation Dyslipidemia Dietary Supplement: 300 g of strawberry, raspberry and cloudberry Dietary Supplement: 400 g of bilberry Other: Control diet

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Diet Rich in Nordic Berries on Gut Microbiota, Glucose and Lipid Metabolism and Metabolism on Fenolic Compounds
Study Start Date : January 2006
Primary Completion Date : December 2006
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SRC
Strawberry, raspberry and cloudberry intervention for 8 weeks
Dietary Supplement: 300 g of strawberry, raspberry and cloudberry
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.
Experimental: BB
Bilberry intervention for 8 weeks
Dietary Supplement: 400 g of bilberry
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.
No Intervention: C
Control diet intervention with restrictions in berry consumption
Other: Control diet
Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks

Outcome Measures

Primary Outcome Measures :
  1. Glucose level [ Time Frame: week 8 ]
    Fasting glucose level oral glucose tolerance status at study week 8

  2. Cholesterol level [ Time Frame: week 8 ]
    total, HDL and LDL cholesterol level at the study week 8

  3. Inflammation markers [ Time Frame: week 8 ]
    Various inflammation markers were measured at the study week 8

Secondary Outcome Measures :
  1. Markers of sterol metabolism [ Time Frame: week 8 ]
    Markers of cholesterol absorption and synthesis were measured

  2. gene expression in PBMCs [ Time Frame: study week 8 ]
    Global gene expression analyses in peripheral mononuclear cells (PBMC)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414647

University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
Kuopio, Finland, FIN-70211
Sponsors and Collaborators
Marjukka Kolehmainen
VTT Technical Research Centre, Finland
Principal Investigator: Riitta Törrönen, Adjunct Professor University of Eastern Finland
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01414647     History of Changes
Other Study ID Numbers: 124//2005
40361/05 ( Other Grant/Funding Number: Tekes, National Technology Agency of Finland )
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Marjukka Kolehmainen, University of Eastern Finland:
Vaccinium myrtillus
Metabolic syndrome
Glucose metabolism
Lipid metabolism
Gene expression

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Intolerance
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders