Study of Oral Anthocyanins on Insulin Resistance

Study Overview
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Brief Summary
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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.

Official Title
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Study of Oral Anthocyanins on Insulin Resistance

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Mirtoselect


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blaeberry concentrated caspule<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo capsules containing lactose<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Glucose Tolerance Test | Change in Oral Glucose Tolerance following intervention | Day 0 and 21 days post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose/insulin | Change in fasting blood glucose/insulin in response to intervention | Day 0, 7, 14, and 21 days post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue, inflammation