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Type 2 DiabetesNCT01860547

Effects of Berries and Berry Fractions on Metabolic Diseases

A study testing Bilberries, Sea buckthorn berry and Sea buckthorn phenolic extract in people with Type 2 Diabetes and Atherosclerosis, run by University of Turku at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes, Atherosclerosis
What is being tested?
Bilberries, Sea buckthorn berry and Sea buckthorn phenolic extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteFinland
Study dates
Jun 2008to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University of Turku, Dept of Biochemistry and Food Chemistry

    Turku, FI-20014

Other trials in Finland

About this study

Official title: 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.

Read the 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.

Being tested
Bilberries, Sea buckthorn berry, Sea buckthorn phenolic extract, Sea buckthorn oil
Medical subject headings
Diabetes Mellitus, Type 2, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BilberriesDietary supplement

    Frozen bilberries, 100 g/d

  • Sea buckthorn berryDietary supplement

    Dried sea buckthorn berries, 20 g/d

  • Sea buckthorn phenolic extractDietary supplement

    Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)

  • Sea buckthorn oilDietary supplement

    Sea buckthorn oil, 4 g (8 capsules)/d

Study groups in NCT01860547
Study groupRoleWhat they receive
bilberryExperimentalNot described
Receives: Dietary Supplement: Bilberries
sea buckthorn berryExperimentalNot described
Receives: Dietary Supplement: Sea buckthorn berry
sea buckthorn phenolic extractExperimentalNot described
Receives: Dietary Supplement: Sea buckthorn phenolic extract
sea buckthorn oilExperimentalNot described
Receives: Dietary Supplement: Sea buckthorn oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Alanine aminotransferase (ALAT)

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Secondary outcomes (14)

  1. Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  2. Plasma glucose

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  3. Serum gamma-glutamyl transpeptidase

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  4. Serum high-sensitivity C-reactive protein

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  5. Serum insulin

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  6. Serum soluble intercellular adhesion molecule

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  7. Serum tumor necrosis factor -alpha

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  8. Body mass index

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  9. Serum soluble vascular cell adhesion molecule

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  10. Serum adiponectin

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  11. Serum interleukine-6

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  12. Weight

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  13. Waist circumference

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

  14. Body composition

    Measured: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startJun 2008
  3. Primary completionJun 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860547
Sponsor's protocol ID
TYBID1
Status last verified
May 2013
First submitted
29 Apr 2013
Last updated
22 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21224867

  • 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.

    PubMed 23945716

Questions about this trial

What is this clinical trial studying?

A study testing Bilberries, Sea buckthorn berry and Sea buckthorn phenolic extract in people with Type 2 Diabetes and Atherosclerosis, run by University of Turku at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Alanine aminotransferase (ALAT) (time frame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860547, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.

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