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Completed

NCT Number: NCT01860547

Effects of Berries and Berry Fractions on Metabolic Diseases

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.

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku, Dept of Biochemistry and Food Chemistry

Turku, FI-20014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilberries

Dietary Supplement

Frozen bilberries, 100 g/d

Sea buckthorn berry

Dietary Supplement

Dried sea buckthorn berries, 20 g/d

Sea buckthorn phenolic extract

Dietary Supplement

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

Dietary Supplement

Sea buckthorn oil, 4 g (8 capsules)/d

Primary outcomes

  1. Serum Alanine aminotransferase (ALAT)

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

Secondary outcomes

  1. Serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triacylglycerols

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

  2. Plasma glucose

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

  3. Serum gamma-glutamyl transpeptidase

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

  4. Serum high-sensitivity C-reactive protein

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

  5. Serum insulin

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

  6. Serum soluble intercellular adhesion molecule

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

  7. Serum tumor necrosis factor -alpha

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

  8. Body mass index

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

  9. Serum soluble vascular cell adhesion molecule

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

  10. Serum adiponectin

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

  11. Serum interleukine-6

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

  12. Weight

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

  13. Waist circumference

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

  14. Body composition

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

Other outcomes

  1. Subclasses of serum lipoproteins, serum fatty acids and lipid classes of serum

    Time frame: Change from beginning to end of each berry treatment (duration of treatments average 33-35 days)

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Aromtech Ltd.
  • Fazer
  • Finnish Berry Powders Ltd.
  • Kiantama Ltd.
  • Pakkasmarja
  • Saarioinen
  • Satakunta Sea Buckthorn Society

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 22, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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