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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01414647
Other study ID # 124//2005
Secondary ID 40361/05
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date March 2010

Study information

Verified date May 2018
Source University of Eastern Finland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 2010
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.
Other:
Control diet
Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks

Locations

Country Name City State
Finland University of Eastern Finland, Dpet of Public Health and Clinical Nutrition Kuopio

Sponsors (2)

Lead Sponsor Collaborator
Marjukka Kolehmainen VTT Technical Research Centre, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose level Fasting glucose level oral glucose tolerance status at study week 8 week 8
Primary Cholesterol level total, HDL and LDL cholesterol level at the study week 8 week 8
Primary Inflammation markers Various inflammation markers were measured at the study week 8 week 8
Secondary Markers of sterol metabolism Markers of cholesterol absorption and synthesis were measured week 8
Secondary gene expression in PBMCs Global gene expression analyses in peripheral mononuclear cells (PBMC) study week 8
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