Effects of Berries and Berry Fractions on Metabolic Diseases

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Atherosclerosis
• Interventions: Dietary Supplement: Bilberries; Dietary Supplement: Sea buckthorn berry; Dietary Supplement: Sea buckthorn phenolic extract; Dietary Supplement: Sea buckthorn oil

• Registration Number: NCT01860547
• Lead Sponsor: University of Turku

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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Study First Submitted: 2013-04-29
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-20
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bilberry	Bilberries	-
sea buckthorn berry	Sea buckthorn berry	-
sea buckthorn phenolic extract	Sea buckthorn phenolic extract	-
sea buckthorn oil	Sea buckthorn oil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 high-sensitivity C-reactive protein	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 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)

Trial Locations

Locations (1)

University of Turku, Dept of Biochemistry and Food Chemistry; 🇫🇮 Turku, Finland