NCT01414647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

August 10, 2011

Last Update Submit

May 12, 2018

Conditions

Keywords

BilberryVaccinium myrtillusMetabolic syndromeGlucose metabolismLipid metabolismInflammationGene expression

Outcome Measures

Primary Outcomes (3)

  • Glucose level

    Fasting glucose level oral glucose tolerance status at study week 8

    week 8

  • Cholesterol level

    total, HDL and LDL cholesterol level at the study week 8

    week 8

  • Inflammation markers

    Various inflammation markers were measured at the study week 8

    week 8

Secondary Outcomes (2)

  • Markers of sterol metabolism

    week 8

  • gene expression in PBMCs

    study week 8

Study Arms (3)

SRC

EXPERIMENTAL

Strawberry, raspberry and cloudberry intervention for 8 weeks

Dietary Supplement: 300 g of strawberry, raspberry and cloudberry

BB

EXPERIMENTAL

Bilberry intervention for 8 weeks

Dietary Supplement: 400 g of bilberry

C

EXPERIMENTAL

Control diet with restricted berry consumption

Other: Control diet

Interventions

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.

SRC
400 g of bilberryDIETARY_SUPPLEMENT

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.

BB

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

Also known as: Diet with restricted consumption of berries.
C

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • chronic diseases
  • use of lipid lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland, Dpet of Public Health and Clinical Nutrition

Kuopio, FIN-70211, Finland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Metabolic SyndromeGlucose IntoleranceDyslipidemiasInflammation

Interventions

Vaccinium myrtillus extractDiet

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemiaLipid Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Riitta Törrönen, Adjunct Professor

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

January 1, 2006

Primary Completion

December 1, 2006

Study Completion

March 1, 2010

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations