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Study of Oral Anthocyanins on Insulin Resistance

Study of Oral Anthocyanins on Insulin Resistance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180712
Enrollment
16
Registered
2010-08-12
Start date
2010-06-30
Completion date
2019-05-31
Last updated
2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue, inflammation

Brief summary

Dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions The genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. The association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance. The aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.

Interventions

DIETARY_SUPPLEMENTMirtoselect

Male subjects (BMI \> 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance. Volunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days.

Sponsors

University of Aberdeen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Obese male subjects (BMI \> 30) * Aged \> 40 and \< 70 years of age * Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance * All the obese subjects will have a waist circumference over 40 inches * All subjects must live the Aberdeenshire area of Scotland

Exclusion criteria

Medical

Design outcomes

Primary

MeasureTime frameDescription
Oral Glucose Tolerance TestDay 0 and 21 days post interventionChange in Oral Glucose Tolerance following intervention

Secondary

MeasureTime frameDescription
Fasting blood glucose/insulinDay 0, 7, 14, and 21 days post interventionChange in fasting blood glucose/insulin in response to intervention

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026