Effects of Berries and Berry Fractions on Metabolic Diseases
The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedMay 22, 2013
May 1, 2013
1 year
April 29, 2013
May 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Alanine aminotransferase (ALAT)
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Secondary Outcomes (14)
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)
Plasma glucose
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum gamma-glutamyl transpeptidase
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum high-sensitivity C-reactive protein
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum insulin
Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
- +9 more secondary outcomes
Other Outcomes (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)
Study Arms (4)
bilberry
EXPERIMENTALsea buckthorn berry
EXPERIMENTALsea buckthorn phenolic extract
EXPERIMENTALsea buckthorn oil
EXPERIMENTALInterventions
Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turkulead
- Pakkasmarjacollaborator
- Saarioinencollaborator
- Kiantama Ltd.collaborator
- Aromtech Ltd.collaborator
- Fazercollaborator
- Satakunta Sea Buckthorn Societycollaborator
- Finnish Berry Powders Ltd.collaborator
Study Sites (1)
University of Turku, Dept of Biochemistry and Food Chemistry
Turku, FI-20014, Finland
Related Publications (2)
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.
PMID: 21224867RESULTLarmo 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.
PMID: 23945716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jukka-Pekka Suomela, Ph.D.
University of Turku
- STUDY DIRECTOR
Heikki Kallio, Prof.
University of Turku
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Lecturer
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 22, 2013
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
May 22, 2013
Record last verified: 2013-05