Study of Oral Anthocyanins on Insulin Resistance

NCT ID: NCT01180712

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2019-05-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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/)

Group Type: ACTIVE_COMPARATOR

Mirtoselect

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Mirtoselect

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• 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,
• Digoxin and antiarrhythmics,
• Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),
• Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigel Hoggard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen Rowett Institute of Nutrition and Health

Locations

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 16979328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17533652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17265471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19515743 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Rowett 901

Identifier Type: OTHER

Identifier Source: secondary_id

REC 10/S0802/27

Identifier Type: -

Identifier Source: org_study_id