The Health Effect of Diet Rich in Nordic Berries (Berry)
Primary Purpose
Metabolic Syndrome, Impaired Glucose Tolerance, Low-grade Inflammation
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
300 g of strawberry, raspberry and cloudberry
400 g of bilberry
Control diet
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Bilberry, Vaccinium myrtillus, Metabolic syndrome, Glucose metabolism, Lipid metabolism, Inflammation, Gene expression
Eligibility 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
Sites / Locations
- University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SRC
BB
C
Arm Description
Strawberry, raspberry and cloudberry intervention for 8 weeks
Bilberry intervention for 8 weeks
Control diet with restricted berry consumption
Outcomes
Primary Outcome Measures
Glucose level
Fasting glucose level oral glucose tolerance status at study week 8
Cholesterol level
total, HDL and LDL cholesterol level at the study week 8
Inflammation markers
Various inflammation markers were measured at the study week 8
Secondary Outcome Measures
Markers of sterol metabolism
Markers of cholesterol absorption and synthesis were measured
gene expression in PBMCs
Global gene expression analyses in peripheral mononuclear cells (PBMC)
Full Information
NCT ID
NCT01414647
First Posted
August 10, 2011
Last Updated
May 12, 2018
Sponsor
Marjukka Kolehmainen
Collaborators
VTT Technical Research Centre, Finland
1. Study Identification
Unique Protocol Identification Number
NCT01414647
Brief Title
The Health Effect of Diet Rich in Nordic Berries
Acronym
Berry
Official Title
The Effect of Diet Rich in Nordic Berries on Gut Microbiota, Glucose and Lipid Metabolism and Metabolism on Fenolic Compounds
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjukka Kolehmainen
Collaborators
VTT Technical Research Centre, Finland
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Impaired Glucose Tolerance, Low-grade Inflammation, Dyslipidemia
Keywords
Bilberry, Vaccinium myrtillus, Metabolic syndrome, Glucose metabolism, Lipid metabolism, Inflammation, Gene expression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRC
Arm Type
Experimental
Arm Description
Strawberry, raspberry and cloudberry intervention for 8 weeks
Arm Title
BB
Arm Type
Experimental
Arm Description
Bilberry intervention for 8 weeks
Arm Title
C
Arm Type
Experimental
Arm Description
Control diet with restricted berry consumption
Intervention Type
Dietary Supplement
Intervention Name(s)
300 g of strawberry, raspberry and cloudberry
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
400 g of bilberry
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control diet
Other Intervention Name(s)
Diet with restricted consumption of berries.
Intervention Description
Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks
Primary Outcome Measure Information:
Title
Glucose level
Description
Fasting glucose level oral glucose tolerance status at study week 8
Time Frame
week 8
Title
Cholesterol level
Description
total, HDL and LDL cholesterol level at the study week 8
Time Frame
week 8
Title
Inflammation markers
Description
Various inflammation markers were measured at the study week 8
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Markers of sterol metabolism
Description
Markers of cholesterol absorption and synthesis were measured
Time Frame
week 8
Title
gene expression in PBMCs
Description
Global gene expression analyses in peripheral mononuclear cells (PBMC)
Time Frame
study week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riitta Törrönen, Adjunct Professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23934737
Citation
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.
Results Reference
derived
PubMed Identifier
22961907
Citation
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.
Results Reference
derived
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The Health Effect of Diet Rich in Nordic Berries
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