Study of Acute Oral Administration of Anthocyanins on Insulin Resistance

This study is currently recruiting participants.
Verified June 2013 by University of Aberdeen
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01245270
First received: November 16, 2010
Last updated: June 24, 2013
Last verified: June 2013
  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 acute effects of anthocyanin supplementation on insulin resistance, inflammation and bioavailability following a single acute dose taken orally as a capsule of a concentrated bilberry/blaeberry extract which is rich in anthocyanins. This study will also provide information on the levels of anthocyanins in the patients' blood, urine and faeces.


Condition Intervention
Type 2 Diabetes
Dietary Supplement: Mirtoselect

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

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Plasma glucose [ Time Frame: Plasma will also be collected over 24 hours post single intervention ] [ Designated as safety issue: No ]
    Change in non fasted glucose following single intervention or placebo over the 24hr period


Secondary Outcome Measures:
  • Bioavailability in plasma [ Time Frame: Plasma will also be collected -15,-10, -5, 15, 30, 45, 60, 90, 120, 150, and 300 minutes and 24 hours post intervention ] [ Designated as safety issue: No ]
    To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.

  • Bioavailability in urine [ Time Frame: Urine will also be collected (if possible) 0, 1, 3 and 5 hours, with all urine collected within the 24 hour time period post intervention ] [ Designated as safety issue: No ]
    To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.

  • Bioavailability in faeces [ Time Frame: Faecal sample will be collected 24 hr post intervention ] [ Designated as safety issue: No ]
    To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.


Estimated Enrollment: 12
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blaeberry concentrated capsule
Volunteers will be given a single capsule of 0.47 grams of mirtoselect (a concentrated blaeberry extract)
Dietary Supplement: Mirtoselect

Male subjects aged >40 and <70 years, with type 2 diabetes controlling their diabetes by diet alone closely matched for adiposity as determined by waist circumference (n=12).

Volunteers will be randomised double blinded into two groups (n=12 per group) and given a single capsule of either 0.47 grams of a blaeberry extract (mirtoselect provided by Indena S.p.A (http://www.mirtoselect.info/) or a control capsule. Following a two week wash out period the volunteers will be asked to take a second single capsule of either of 0.47 grams of mirtoselect or a control gelatin capsule in a cross over study, the opposite of what they took the first time.

Placebo Comparator: Placebo caspules
Volunteers will be given a single placebo capsule
Dietary Supplement: Mirtoselect

Male subjects aged >40 and <70 years, with type 2 diabetes controlling their diabetes by diet alone closely matched for adiposity as determined by waist circumference (n=12).

Volunteers will be randomised double blinded into two groups (n=12 per group) and given a single capsule of either 0.47 grams of a blaeberry extract (mirtoselect provided by Indena S.p.A (http://www.mirtoselect.info/) or a control capsule. Following a two week wash out period the volunteers will be asked to take a second single capsule of either of 0.47 grams of mirtoselect or a control gelatin capsule in a cross over study, the opposite of what they took the first time.


  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects
  • Aged >40 and <70
  • Clinical diagnosis of Type 2 diabetes controlling their diabetes by diet alone
  • All subjects must live in the Aberdeenshire area of Scotland

Exclusion Criteria:

  • Medical exclusion criteria
  • Clinical diagnosis of thromboembolic or coagulation disease
  • Clinical diagnosis of unregulated thyroid disease
  • Clinical diagnosis of kidney disease
  • Clinical diagnosis of severe gastrointestinal disorders
  • History of Alcohol or any other substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245270

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
Contact: Nigel Hoggard, PhD    01224 716655    N.Hoggard@abdn.ac.uk   
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

Publications:
Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01245270     History of Changes
Other Study ID Numbers: REC 10/S0801/54, 902
Study First Received: November 16, 2010
Last Updated: June 24, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
anthocyanin
blaeberries
bilberries
blueberries
mirtoselect
glucose disposal

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on April 20, 2014