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


N/A
30 Years
55 Years
Not Enrolling
Female
Type 2 Diabetes, Atherosclerosis

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Trial Information

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


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 (Hippophaƫ
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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Serum Alanine aminotransferase (ALAT)

Outcome Time Frame:

Change from beginnig to end of each berry treatment (duration of treatments average 33-35 days)

Safety Issue:

No

Principal Investigator

Jukka-Pekka Suomela, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Turku

Authority:

Finland: Ministry of Social Affairs and Health

Study ID:

TYBID1

NCT ID:

NCT01860547

Start Date:

June 2008

Completion Date:

August 2009

Related Keywords:

  • Type 2 Diabetes
  • Atherosclerosis
  • Atherosclerosis
  • Diabetes Mellitus, Type 2
  • Metabolic Diseases

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