Study of Oral Anthocyanins on Insulin Resistance

Type 2 Diabetes Clinical Trial

Official title:

Study of Oral Anthocyanins on Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180712
• Other study ID #: REC 10/S0802/27
• Secondary ID: Rowett 901
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Mirtoselect
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.

Locations

Country	Name	City	State
United Kingdom	University of Aberdeen Rowett Institute of Nutrition and Health	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. Epub 2006 Sep 18. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Glucose Tolerance Test	Change in Oral Glucose Tolerance following intervention	Day 0 and 21 days post intervention
Secondary	Fasting blood glucose/insulin	Change in fasting blood glucose/insulin in response to intervention	Day 0, 7, 14, and 21 days post intervention