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

This study has been completed.
Sponsor:
Collaborator:
VTT Technical Research Centre, Finland
Information provided by (Responsible Party):
Marjukka Kolehmainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01414647
First received: August 10, 2011
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • Glucose level [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Fasting glucose level oral glucose tolerance status at study week 8

  • Cholesterol level [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    total, HDL and LDL cholesterol level at the study week 8

  • Inflammation markers [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Various inflammation markers were measured at the study week 8


Secondary Outcome Measures:
  • Markers of sterol metabolism [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Markers of cholesterol absorption and synthesis were measured

  • gene expression in PBMCs [ Time Frame: study week 8 ] [ Designated as safety issue: No ]
    Global gene expression analyses in peripheral mononuclear cells (PBMC)


Enrollment: 56
Study Start Date: January 2006
Study Completion Date: March 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414647

Locations
Finland
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
Investigators
Principal Investigator: Riitta Törrönen, Adjunct Professor University of Eastern Finland
  More Information

No publications provided by University of Eastern Finland

Additional 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
Study First Received: August 10, 2011
Last Updated: April 16, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
Bilberry
Vaccinium myrtillus
Metabolic syndrome
Glucose metabolism
Lipid metabolism
Inflammation
Gene expression

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Syndrome
Dyslipidemias
Glucose Intolerance
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Lipid Metabolism Disorders
Hyperglycemia

ClinicalTrials.gov processed this record on September 29, 2014