NCT01180712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

8.9 years

First QC Date

August 11, 2010

Last Update Submit

August 1, 2019

Conditions

Type 2 Diabetes

Keywords

anthocyaninblaeberriesbilberriesblueberriesmirtoselecttype 2 diabetesinsulin resistanceAdipose tissueinflammation

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Tolerance Test

    Change in Oral Glucose Tolerance following intervention

    Day 0 and 21 days post intervention

Secondary Outcomes (1)

  • Fasting blood glucose/insulin

    Day 0, 7, 14, and 21 days post intervention

Study Arms (2)

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/)

Dietary Supplement: Mirtoselect

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.

Dietary Supplement: Mirtoselect

Interventions

MirtoselectDIETARY_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.

Blaeberry concentrated caspulePlacebo capsules containing lactose

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • Oral steroids,
  • Tricyclic antidepressants, neuroleptics,
  • Anticoagulants,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, AB21 9SB, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 16979328BACKGROUND

  • 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.

    PMID: 17533652BACKGROUND

  • 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.

    PMID: 17265471BACKGROUND

  • 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.

    PMID: 19515743BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceInflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nigel Hoggard, PhD

    University of Aberdeen Rowett Institute of Nutrition and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 12, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

August 2, 2019

Record last verified: 2019-08

Locations

GB(1)