Type 2 Diabetes Clinical Trial
Official title:
The Effect of the Bioactives of Sea Buckthorn and Bilberry on the Risk of Metabolic Diseases
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | University of Turku, Dept of Biochemistry and Food Chemistry | Turku |
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 |
Finland,
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
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 |
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