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Effects of Berries and Berry Fractions on Metabolic Diseases

Primary Purpose

Type 2 Diabetes, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Bilberries
Sea buckthorn berry
Sea buckthorn phenolic extract
Sea buckthorn oil
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 26-34
  • total cholesterol 4.5-8 mmol/l
  • LDL chol >2.5 mmol/l
  • triglycerides <4 mmol/l
  • glucose <6 mmol/l
  • insulin <25 mU/l
  • blood pressure <160/99 mm Hg
  • hemoglobin >120 g/l
  • thyroid-stimulating hormone 0.3-4.2 mU/l
  • ALAT <60 U/l
  • creatinine <115 umol/l

Exclusion Criteria:

  • pregnancy
  • menopause,
  • regular smoking
  • previously diagnosed diabetes (other than gestational)
  • thyroid, renal, hematological, or hepatic dysfunction
  • previous myocardial infarction
  • cardiovascular medication
  • treatment with regular medication other than allergy medication or joint lubricates
  • on-going inflammatory disease

Sites / Locations

  • University of Turku, Dept of Biochemistry and Food Chemistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

bilberry

sea buckthorn berry

sea buckthorn phenolic extract

sea buckthorn oil

Arm Description

Outcomes

Primary Outcome Measures

Serum Alanine aminotransferase (ALAT)

Secondary Outcome Measures

Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols
Plasma glucose
Serum gamma-glutamyl transpeptidase
Serum high-sensitivity C-reactive protein
Serum insulin
Serum soluble intercellular adhesion molecule
Serum tumor necrosis factor -alpha
Body mass index
Serum soluble vascular cell adhesion molecule
Serum adiponectin
Serum interleukine-6
Weight
Waist circumference
Body composition

Full Information

First Posted
April 29, 2013
Last Updated
May 20, 2013
Sponsor
University of Turku
Collaborators
Pakkasmarja, Saarioinen, Kiantama Ltd., Aromtech Ltd., Fazer, Satakunta Sea Buckthorn Society, Finnish Berry Powders Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01860547
Brief Title
Effects of Berries and Berry Fractions on Metabolic Diseases
Official Title
The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
Pakkasmarja, Saarioinen, Kiantama Ltd., Aromtech Ltd., Fazer, Satakunta Sea Buckthorn Society, Finnish Berry Powders Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic diseases.
Detailed Description
The aim of the project was to investigate whether it is possible to reduce the risk of metabolic diseases with supplementing the diet with sea buckthorn berries (Hippophaë rhamnoides), their bioactive fractions, and bilberries (Vaccinium myrtillus). The study design was a randomized cross-over clinical trial. The participants were slightly and moderately overweight female subjects. In total, 110 female volunteers were recruited, and they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic extract and sea buckthorn oil) in a randomized order for 33-35 days. Each intervention was followed by a wash-out period of 30-39 days. Blood samples were drawn and physical measurements were performed after each period. Eighty volunteers completed the study. Different markers of lipid and carbohydrate metabolism and inflammation were measured form the blood samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilberry
Arm Type
Experimental
Arm Title
sea buckthorn berry
Arm Type
Experimental
Arm Title
sea buckthorn phenolic extract
Arm Type
Experimental
Arm Title
sea buckthorn oil
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Bilberries
Intervention Description
Frozen bilberries, 100 g/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Sea buckthorn berry
Intervention Description
Dried sea buckthorn berries, 20 g/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Sea buckthorn phenolic extract
Intervention Description
Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Sea buckthorn oil
Intervention Description
Sea buckthorn oil, 4 g (8 capsules)/d
Primary Outcome Measure Information:
Title
Serum Alanine aminotransferase (ALAT)
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Secondary Outcome Measure Information:
Title
Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Plasma glucose
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum gamma-glutamyl transpeptidase
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum high-sensitivity C-reactive protein
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum insulin
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum soluble intercellular adhesion molecule
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum tumor necrosis factor -alpha
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Body mass index
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum soluble vascular cell adhesion molecule
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum adiponectin
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Serum interleukine-6
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Weight
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Waist circumference
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Title
Body composition
Time Frame
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Other Pre-specified Outcome Measures:
Title
Subclasses of serum lipoproteins, serum fatty acids and lipid classes of serum
Time Frame
Change from beginning to end of each berry treatment (duration of treatments average 33-35 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 26-34 total cholesterol 4.5-8 mmol/l LDL chol >2.5 mmol/l triglycerides <4 mmol/l glucose <6 mmol/l insulin <25 mU/l blood pressure <160/99 mm Hg hemoglobin >120 g/l thyroid-stimulating hormone 0.3-4.2 mU/l ALAT <60 U/l creatinine <115 umol/l Exclusion Criteria: pregnancy menopause, regular smoking previously diagnosed diabetes (other than gestational) thyroid, renal, hematological, or hepatic dysfunction previous myocardial infarction cardiovascular medication treatment with regular medication other than allergy medication or joint lubricates on-going inflammatory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jukka-Pekka Suomela, Ph.D.
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heikki Kallio, Prof.
Organizational Affiliation
University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
University of Turku, Dept of Biochemistry and Food Chemistry
City
Turku
ZIP/Postal Code
FI-20014
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21224867
Citation
Lehtonen HM, Suomela JP, Tahvonen R, Yang B, Venojarvi M, Viikari J, Kallio H. Different berries and berry fractions have various but slightly positive effects on the associated variables of metabolic diseases on overweight and obese women. Eur J Clin Nutr. 2011 Mar;65(3):394-401. doi: 10.1038/ejcn.2010.268. Epub 2011 Jan 12.
Results Reference
result
PubMed Identifier
23945716
Citation
Larmo PS, Kangas AJ, Soininen P, Lehtonen HM, Suomela JP, Yang B, Viikari J, Ala-Korpela M, Kallio HP. Effects of sea buckthorn and bilberry on serum metabolites differ according to baseline metabolic profiles in overweight women: a randomized crossover trial. Am J Clin Nutr. 2013 Oct;98(4):941-51. doi: 10.3945/ajcn.113.060590. Epub 2013 Aug 14.
Results Reference
derived

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Effects of Berries and Berry Fractions on Metabolic Diseases

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