Effects of Berries and Berry Fractions on Metabolic Diseases

May 20, 2013 updated by: Jukka-Pekka Suomela, University of Turku

The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FI-20014
        • University of Turku, Dept of Biochemistry and Food Chemistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bilberry
Dietary supplement: Bilberries
Frozen bilberries, 100 g/d
Experimental: sea buckthorn berry
Dietary supplement: Sea buckthorn berry
Dried sea buckthorn berries, 20 g/d
Experimental: sea buckthorn phenolic extract
Dietary supplement: Sea buckthorn phenolic extract
Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)
Experimental: sea buckthorn oil
Dietary supplement: Sea buckthorn oil
Sea buckthorn oil, 4 g (8 capsules)/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Alanine aminotransferase (ALAT)
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Plasma glucose
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum gamma-glutamyl transpeptidase
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum high-sensitivity C-reactive protein
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum insulin
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum soluble intercellular adhesion molecule
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum tumor necrosis factor -alpha
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Body mass index
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum soluble vascular cell adhesion molecule
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum adiponectin
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum interleukine-6
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Weight
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Waist circumference
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Body composition
Time Frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Other Outcome Measures

Outcome Measure
Time Frame
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)
Change from beginning to end of each berry treatment (duration of treatments average 33-35 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Fazer
Aromtech Ltd.
Pakkasmarja
Saarioinen
Kiantama Ltd.
Satakunta Sea Buckthorn Society
Finnish Berry Powders Ltd.

Investigators

  • Principal Investigator: Jukka-Pekka Suomela, Ph.D., University of Turku
  • Study Director: Heikki Kallio, Prof., University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYBID1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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