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Study of Oral Anthocyanins on Insulin Resistance

This study is currently recruiting participants.
Verified December 2012 by University of Aberdeen
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01180712
First received: August 11, 2010
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Dietary Supplement: Mirtoselect

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Oral Anthocyanins on Insulin Resistance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Oral Glucose Tolerance Test [ Time Frame: Day 0 and 21 days post intervention ] [ Designated as safety issue: No ]
    Change in Oral Glucose Tolerance following intervention


Secondary Outcome Measures:
  • Fasting blood glucose/insulin [ Time Frame: Day 0, 7, 14, and 21 days post intervention ] [ Designated as safety issue: No ]
    Change in fasting blood glucose/insulin in response to intervention

  • Adipose tissue gene expression [ Time Frame: Day 0 and 21 days post intervention ] [ Designated as safety issue: No ]
    Change in inflammatory gene expression in sub C adipose tissue biopsies following intervention


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180712

Contacts
Contact: Nigel Hoggard, PhD 01224 716655 n.hoggard@abdn.ac.uk

Locations
United Kingdom
University of Aberdeen Rowett Institute of Nutrition and Health Recruiting
Aberdeen, United Kingdom, AB21 9SB
Principal Investigator: Nigel Hoggard, PhD            
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Nigel Hoggard, PhD University of Aberdeen Rowett Institute of Nutrition and Health
  More Information

Additional Information:
Rowett Human Nutrition Unit volunteer page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01180712     History of Changes
Other Study ID Numbers: REC 10/S0802/27, Rowett 901
Study First Received: August 11, 2010
Last Updated: December 12, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
anthocyanin
blaeberries
bilberries
blueberries
mirtoselect
 type 2 diabetes
insulin resistance
Adipose tissue
inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013