Study of Oral Anthocyanins on Insulin Resistance

University of Aberdeen

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Mirtoselect

Study type: Interventional

Funder types: Other

Identifiers

NCT01180712

Rowett 901 (Other Identifier)

REC 10/S0802/27

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Blaeberry concentrated caspule

Active Comparator group

Description:

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/)

Treatment:

Dietary Supplement: Mirtoselect

Placebo capsules containing lactose

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Mirtoselect