Effects of Berries and Berry Fractions on Metabolic Diseases

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860547
• Other study ID #: TYBID1
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 20, 2013
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2013
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Metabolic Diseases
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Bilberries
Frozen bilberries, 100 g/d
• Sea buckthorn berry
Dried sea buckthorn berries, 20 g/d
• Sea 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)
• Sea buckthorn oil
Sea buckthorn oil, 4 g (8 capsules)/d

Locations

Country	Name	City	State
Finland	University of Turku, Dept of Biochemistry and Food Chemistry	Turku

Sponsors (8)

Lead Sponsor	Collaborator
University of Turku	Aromtech Ltd., Fazer Bakeries Ltd., Finnish Berry Powders Ltd., Kiantama Ltd., Pakkasmarja Ltd., Saarioinen Ltd., Satakunta Sea Buckthorn Society

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Lehtonen HM, Suomela JP, Tahvonen R, Yang B, Venojärvi 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 Nut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	Serum Alanine aminotransferase (ALAT)		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	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)	No
Secondary	Plasma glucose		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum gamma-glutamyl transpeptidase		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum high-sensitivity C-reactive protein		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum insulin		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum soluble intercellular adhesion molecule		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum tumor necrosis factor -alpha		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Body mass index		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum soluble vascular cell adhesion molecule		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum adiponectin		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Serum interleukine-6		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Weight		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Waist circumference		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No
Secondary	Body composition		Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)	No