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| ID | Type | Description | Link |
|---|---|---|---|
| Rowett 901 | Other Identifier | Rowett institute study code |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blaeberry concentrated caspule | Active Comparator | 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/) |
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| Placebo capsules containing lactose | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtoselect | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Glucose Tolerance Test | Change in Oral Glucose Tolerance following intervention | Day 0 and 21 days post intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Medical exclusion criteria:
Chronic illness, including:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Hoggard, PhD | University of Aberdeen Rowett Institute of Nutrition and Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aberdeen Rowett Institute of Nutrition and Health | Aberdeen | AB21 9SB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16979328 | Background | 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. doi: 10.1016/j.phymed.2006.08.005. Epub 2006 Sep 18. | |
| 17533652 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2014 | Aug 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. doi: 10.1002/mnfr.200700002. |
| 17265471 | Background | 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. doi: 10.1002/jnr.21205. |
| 19515743 | Background | 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. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |