Clinical trial NCT01414647: The Health Effect of Diet Rich in Nordic Berries
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Impaired Glucose Tolerance
Low-grade Inflammation
Dyslipidemia
Keywords: Bilberry
Vaccinium myrtillus
Metabolic syndrome
Glucose metabolism
Lipid metabolism
Inflammation
Gene expression
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: VTT Technical Research Centre, Finland
First posted: 2011-08-11
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Glucose level
timeFrame: week 8
measure: Cholesterol level
timeFrame: week 8
measure: Inflammation markers
timeFrame: week 8
Secondary outcomes:
measure: Markers of sterol metabolism
timeFrame: week 8
measure: gene expression in PBMCs
timeFrame: study week 8
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland, Dpet of Public Health and Clinical Nutrition
Study officials:
affiliation: University of Eastern Finland
name: Riitta Törrönen, Adjunct Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.