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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turku

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fazer
Aromtech Ltd.
Pakkasmarja
Saarioinen
Kiantama Ltd.
Satakunta Sea Buckthorn Society
Finnish Berry Powders Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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