Study of Oral Anthocyanins on Insulin Resistance

• ClinicalTrials.gov Identifier: NCT01180712
• Recruitment Status: Completed
• First Posted: August 12, 2010
• Last Update Posted: August 2, 2019
• Sponsor: University of Aberdeen
• Information provided by (Responsible Party): University of Aberdeen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Dietary Supplement: Mirtoselect	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of Oral Anthocyanins on Insulin Resistance
• Study Start Date: June 2010
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Blaeberry concentrated caspule; 30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance. Volunteers will be given a total daily dose of 1.4 grams of mirtoselect (a concentrated blaeberry extract) a day formulated in hard gelatin capsules (0.47 gram per capsule) administered thrice a day for 21 days. Mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/)	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.
Placebo Comparator: Placebo capsules containing lactose; 30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance. Volunteers will be given a placebo consisting of lactose formulated in hard gelatin capsules administered thrice a day for 21 days.	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.

Outcome Measures

Primary Outcome Measures :

1. Oral Glucose Tolerance Test [ Time Frame: Day 0 and 21 days post intervention ]
   Change in Oral Glucose Tolerance following intervention

Secondary Outcome Measures :

1. Fasting blood glucose/insulin [ Time Frame: Day 0, 7, 14, and 21 days post intervention ]
   Change in fasting blood glucose/insulin in response to intervention

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United Kingdom

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, United Kingdom, AB21 9SB

Sponsors and Collaborators

University of Aberdeen

Investigators

• Principal Investigator: Nigel Hoggard, PhD; University of Aberdeen Rowett Institute of Nutrition and Health

  Study Documents (Full-Text)

Documents provided by University of Aberdeen:

Study Protocol and Statistical Analysis Plan  [PDF] November 12, 2014

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: University of Aberdeen
• ClinicalTrials.gov Identifier: NCT01180712
• Other Study ID Numbers: REC 10/S0802/27; Rowett 901 ( Other Identifier: Rowett institute study code )
• First Posted: August 12, 2010
• Last Update Posted: August 2, 2019
• Last Verified: August 2019

Keywords provided by University of Aberdeen:

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Insulin Resistance; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism