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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01860547

Enrollment

110

Registered

2013-05-22

Start date

2008-06-30

Completion date

2009-08-31

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Type 2 Diabetes

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.

Interventions

DIETARY_SUPPLEMENTBilberries

Frozen bilberries, 100 g/d

DIETARY_SUPPLEMENTSea buckthorn berry

Dried sea buckthorn berries, 20 g/d

DIETARY_SUPPLEMENTSea 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)

DIETARY_SUPPLEMENTSea buckthorn oil

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Serum Alanine aminotransferase (ALAT)	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Secondary

Measure	Time frame
Body mass index	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
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)
Serum soluble intercellular adhesion molecule	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum soluble vascular cell adhesion molecule	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum adiponectin	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum interleukine-6	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Weight	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Waist circumference	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Body composition	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)
Serum tumor necrosis factor -alpha	Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Other

Measure	Time frame
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)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026