Study of Oral Anthocyanins on Insulin Resistance
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ClinicalTrials.gov Identifier: NCT01180712 |
Recruitment Status :
Completed
First Posted : August 12, 2010
Last Update Posted : August 2, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Dietary Supplement: Mirtoselect | Not Applicable |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180712
United Kingdom | |
University of Aberdeen Rowett Institute of Nutrition and Health | |
Aberdeen, United Kingdom, AB21 9SB |
Principal Investigator: | Nigel Hoggard, PhD | University of Aberdeen Rowett Institute of Nutrition and Health |
Documents provided by University of Aberdeen:
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 Key Record Dates |
Last Update Posted: | August 2, 2019 |
Last Verified: | August 2019 |
anthocyanin blaeberries bilberries blueberries mirtoselect |
type 2 diabetes insulin resistance Adipose tissue inflammation |
Diabetes Mellitus, Type 2 Insulin Resistance Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperinsulinism |