Clinical trial NCT01860547: Effects of Berries and Berry Fractions on Metabolic Diseases
Official title: The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Atherosclerosis
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Pakkasmarja
name: Saarioinen
name: Kiantama Ltd.
name: Aromtech Ltd.
name: Fazer
name: Satakunta Sea Buckthorn Society
name: Finnish Berry Powders Ltd.
First posted: 2013-05-22
Enrollment: 110
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Alanine aminotransferase (ALAT)
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Secondary outcomes:
measure: Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Plasma glucose
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum gamma-glutamyl transpeptidase
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum high-sensitivity C-reactive protein
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum insulin
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum soluble intercellular adhesion molecule
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum tumor necrosis factor -alpha
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Body mass index
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum soluble vascular cell adhesion molecule
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum adiponectin
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Serum interleukine-6
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Weight
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Waist circumference
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
measure: Body composition
timeFrame: Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Other outcomes:
measure: Subclasses of serum lipoproteins, serum fatty acids and lipid classes of serum
timeFrame: Change from beginning to end of each berry treatment (duration of treatments average 33-35 days)
Locations:
city: Turku
country: Finland
facility: University of Turku, Dept of Biochemistry and Food Chemistry
Study officials:
affiliation: University of Turku
name: Jukka-Pekka Suomela, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Heikki Kallio, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.