Effects of Berries and Berry Fractions on Metabolic Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases

Conditions
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Type 2 Diabetes, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Bilberries
* Dietary Supplement: Sea buckthorn berry
* Dietary Supplement: Sea buckthorn phenolic extract
* Dietary Supplement: Sea buckthorn oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilberry<br> | Dietary Supplement: Bilberries<br>* Frozen bilberries, 100 g/d<br>|
| Experimental: sea buckthorn berry<br> | Dietary Supplement: Sea buckthorn berry<br>* Dried sea buckthorn berries, 20 g/d<br>|
| Experimental: sea buckthorn phenolic extract<br> | Dietary Supplement: Sea buckthorn phenolic extract<br>* Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)<br>|
| Experimental: sea buckthorn oil<br> | Dietary Supplement: Sea buckthorn oil<br>* Sea buckthorn oil, 4 g (8 capsules)/d<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 tumor necrosis factor -alpha |  | Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days) | 
| Body mass index |  | 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) |