Clinical trial NCT01180712: Study of Oral Anthocyanins on Insulin Resistance
Official title: Study of Oral Anthocyanins on Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: anthocyanin
blaeberries
bilberries
blueberries
mirtoselect
type 2 diabetes
insulin resistance
Adipose tissue
inflammation
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria:

* Chronic illness, including:

  * thromboembolic or coagulation disease,
  * unregulated thyroid disease,
  * kidney disease,
  * hepatic disease,
  * severe gastrointestinal disorders,
  * pulmonary disease (e.g. chronic bronchitis, COPD),
* Alcohol or any other substance abuse,
* Eating disorders,
* Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),
* Skin conditions on the abdomen,
* Allergy to skin dressings,

Medication exclusion criteria:

* Oral steroids,
* Tricyclic antidepressants, neuroleptics,
* Anticoagulants,
* Digoxin and antiarrhythmics,
* Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),
* Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin

Primary outcomes:
measure: Oral Glucose Tolerance Test
timeFrame: Day 0 and 21 days post intervention
Secondary outcomes:
measure: Fasting blood glucose/insulin
timeFrame: Day 0, 7, 14, and 21 days post intervention
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen Rowett Institute of Nutrition and Health
Study officials:
affiliation: University of Aberdeen Rowett Institute of Nutrition and Health
name: Nigel Hoggard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martineau LC, Couture A, Spoor D, Benhaddou-Andaloussi A, Harris C, Meddah B, Leduc C, Burt A, Vuong T, Mai Le P, Prentki M, Bennett SA, Arnason JT, Haddad PS. Anti-diabetic properties of the Canadian lowbush blueberry Vaccinium angustifolium Ait. Phytomedicine. 2006 Nov;13(9-10):612-23. doi: 10.1016/j.phymed.2006.08.005. Epub 2006 Sep 18.
citation: Zafra-Stone S, Yasmin T, Bagchi M, Chatterjee A, Vinson JA, Bagchi D. Berry anthocyanins as novel antioxidants in human health and disease prevention. Mol Nutr Food Res. 2007 Jun;51(6):675-83. doi: 10.1002/mnfr.200700002.
citation: Lau FC, Bielinski DF, Joseph JA. Inhibitory effects of blueberry extract on the production of inflammatory mediators in lipopolysaccharide-activated BV2 microglia. J Neurosci Res. 2007 Apr;85(5):1010-7. doi: 10.1002/jnr.21205.
citation: DeFuria J, Bennett G, Strissel KJ, Perfield JW 2nd, Milbury PE, Greenberg AS, Obin MS. Dietary blueberry attenuates whole-body insulin resistance in high fat-fed mice by reducing adipocyte death and its inflammatory sequelae. J Nutr. 2009 Aug;139(8):1510-6. doi: 10.3945/jn.109.105155. Epub 2009 Jun 10.