Berry: The Health Effect of Diet Rich in Nordic Berries

Sponsor

Marjukka Kolehmainen (Other)

Overall Status

Completed

CT.gov ID

NCT01414647

Collaborator

VTT Technical Research Centre, Finland (Other)

Enrollment

Location

Arms

49.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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	Phase
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	N/A

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

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 :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Mar 1, 2010

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.
Experimental: C Control diet with restricted berry consumption	Other: Control diet Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks Other Names: Diet with restricted consumption of berries.

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.

Experimental: C

Control diet with restricted berry consumption

Other: Control diet

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

Other Names:

Diet with restricted consumption of berries.

Outcome Measures

Primary Outcome Measures

Glucose level [week 8]
Fasting glucose level oral glucose tolerance status at study week 8
Cholesterol level [week 8]
total, HDL and LDL cholesterol level at the study week 8
Inflammation markers [week 8]
Various inflammation markers were measured at the study week 8

Secondary Outcome Measures

Markers of sterol metabolism [week 8]
Markers of cholesterol absorption and synthesis were measured
gene expression in PBMCs [study week 8]
Global gene expression analyses in peripheral mononuclear cells (PBMC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

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