Effects of Berries and Berry Fractions on Metabolic Diseases

NCT ID: NCT01860547

Last Updated: 2013-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bilberry

Group Type EXPERIMENTAL

Bilberries

Intervention Type DIETARY_SUPPLEMENT

Frozen bilberries, 100 g/d

sea buckthorn berry

Group Type EXPERIMENTAL

Sea buckthorn berry

Intervention Type DIETARY_SUPPLEMENT

Dried sea buckthorn berries, 20 g/d

sea buckthorn phenolic extract

Group Type EXPERIMENTAL

Sea buckthorn phenolic extract

Intervention Type 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

Group Type EXPERIMENTAL

Sea buckthorn oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilberries

Frozen bilberries, 100 g/d

Intervention Type DIETARY_SUPPLEMENT

Sea buckthorn berry

Dried sea buckthorn berries, 20 g/d

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

Sea buckthorn oil

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pakkasmarja

OTHER

Sponsor Role collaborator

Saarioinen

OTHER

Sponsor Role collaborator

Kiantama Ltd.

UNKNOWN

Sponsor Role collaborator

Aromtech Ltd.

INDUSTRY

Sponsor Role collaborator

Fazer

OTHER

Sponsor Role collaborator

Satakunta Sea Buckthorn Society

UNKNOWN

Sponsor Role collaborator

Finnish Berry Powders Ltd.

UNKNOWN

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jukka-Pekka Suomela

University Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jukka-Pekka Suomela, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Heikki Kallio, Prof.

Role: STUDY_DIRECTOR

University of Turku

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Turku, Dept of Biochemistry and Food Chemistry

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

Lehtonen HM, Suomela JP, Tahvonen R, Yang B, Venojarvi 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 Nutr. 2011 Mar;65(3):394-401. doi: 10.1038/ejcn.2010.268. Epub 2011 Jan 12.

Reference Type RESULT
PMID: 21224867 (View on PubMed)

Larmo PS, Kangas AJ, Soininen P, Lehtonen HM, Suomela JP, Yang B, Viikari J, Ala-Korpela M, Kallio HP. Effects of sea buckthorn and bilberry on serum metabolites differ according to baseline metabolic profiles in overweight women: a randomized crossover trial. Am J Clin Nutr. 2013 Oct;98(4):941-51. doi: 10.3945/ajcn.113.060590. Epub 2013 Aug 14.

Reference Type DERIVED
PMID: 23945716 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TYBID1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Artichoke and Bergamot Phytosome
NCT04697121 COMPLETED NA