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Study of Oral Anthocyanins on Insulin Resistance

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mirtoselect
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue, inflammation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University of Aberdeen Rowett Institute of Nutrition and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Blaeberry concentrated caspule

Placebo capsules containing lactose

Arm 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/)

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.

Outcomes

Primary Outcome Measures

Oral Glucose Tolerance Test
Change in Oral Glucose Tolerance following intervention

Secondary Outcome Measures

Fasting blood glucose/insulin
Change in fasting blood glucose/insulin in response to intervention

Full Information

First Posted
August 11, 2010
Last Updated
August 1, 2019
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT01180712
Brief Title
Study of Oral Anthocyanins on Insulin Resistance
Official Title
Study of Oral Anthocyanins on Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blaeberry concentrated caspule
Arm Type
Active Comparator
Arm 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/)
Arm Title
Placebo capsules containing lactose
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mirtoselect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral Glucose Tolerance Test
Description
Change in Oral Glucose Tolerance following intervention
Time Frame
Day 0 and 21 days post intervention
Secondary Outcome Measure Information:
Title
Fasting blood glucose/insulin
Description
Change in fasting blood glucose/insulin in response to intervention
Time Frame
Day 0, 7, 14, and 21 days post intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Hoggard, PhD
Organizational Affiliation
University of Aberdeen Rowett Institute of Nutrition and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aberdeen Rowett Institute of Nutrition and Health
City
Aberdeen
ZIP/Postal Code
AB21 9SB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16979328
Citation
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.
Results Reference
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PubMed Identifier
17533652
Citation
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.
Results Reference
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PubMed Identifier
17265471
Citation
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.
Results Reference
background
PubMed Identifier
19515743
Citation
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.
Results Reference
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Study of Oral Anthocyanins on Insulin Resistance

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