Effects of Berries and Berry Fractions on Metabolic Diseases

Sponsor
University of Turku (Other)
Overall Status
Completed
CT.gov ID
NCT01860547
Collaborator
Pakkasmarja (Other), Saarioinen (Other), Kiantama Ltd. (Other), Aromtech Ltd. (Industry), Fazer (Other), Satakunta Sea Buckthorn Society (Other), Finnish Berry Powders Ltd. (Other)
110
1
4
14
7.9

Study Details

Study Description

Brief Summary

The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaƫ 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Bilberries
  • Dietary Supplement: Sea buckthorn berry
  • Dietary Supplement: Sea buckthorn phenolic extract
  • Dietary Supplement: Sea buckthorn oil
N/A

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 (Hippophaƫ 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 Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Serum Alanine aminotransferase (ALAT) [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

Secondary Outcome Measures

  1. Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  2. Plasma glucose [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  3. Serum gamma-glutamyl transpeptidase [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  4. Serum high-sensitivity C-reactive protein [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  5. Serum insulin [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  6. Serum soluble intercellular adhesion molecule [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  7. Serum tumor necrosis factor -alpha [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  8. Body mass index [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  9. Serum soluble vascular cell adhesion molecule [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  10. Serum adiponectin [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  11. Serum interleukine-6 [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  12. Weight [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  13. Waist circumference [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

  14. Body composition [Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)]

Other Outcome Measures

  1. Subclasses of serum lipoproteins, serum fatty acids and lipid classes of serum [Change from beginning to end of each berry treatment (duration of treatments average 33-35 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Turku, Dept of Biochemistry and Food Chemistry Turku Finland FI-20014

Sponsors and Collaborators

  • University of Turku
  • Pakkasmarja
  • Saarioinen
  • Kiantama Ltd.
  • Aromtech Ltd.
  • Fazer
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jukka-Pekka Suomela, University Lecturer, University of Turku
ClinicalTrials.gov Identifier:
NCT01860547
Other Study ID Numbers:
  • TYBID1
First Posted:
May 22, 2013
Last Update Posted:
May 22, 2013
Last Verified:
May 1, 2013
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2013