Type 2 DiabetesNCT01180712
Study of Oral Anthocyanins on Insulin Resistance
A study testing Mirtoselect in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Mirtoselect
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical exclusion criteria:
- Chronic illness, including:
- thromboembolic or coagulation disease,
- unregulated thyroid disease,
- kidney disease,
- hepatic disease,
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen Rowett Institute of Nutrition and Health
Aberdeen, AB21 9SB
About this study
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
- Being tested
- Mirtoselect
- Keywords
- anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue, inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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/) Receives: 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. Receives: Dietary Supplement: Mirtoselect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Tolerance Test
Change in Oral Glucose Tolerance following intervention
Measured: Day 0 and 21 days post intervention
Secondary outcomes (1)
Fasting blood glucose/insulin
Change in fasting blood glucose/insulin in response to intervention
Measured: Day 0, 7, 14, and 21 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nigel Hoggard, PhD, Principal investigator, University of Aberdeen Rowett Institute of Nutrition and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180712
- Sponsor's protocol ID
- REC 10/S0802/27
- Other IDs
- Rowett 901
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2010
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16979328Zafra-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.
PubMed 17533652Lau 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.
PubMed 17265471DeFuria 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.
PubMed 19515743
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oral Anthocyanins on Insulin Resistance
- ClinicalTrials.gov ID
- NCT01180712
- Acronym / sponsor ID
- REC 10/S0802/27
- Conditions
- Type 2 Diabetes
- Keywords
- anthocyanin, blaeberries, bilberries, blueberries, mirtoselect, type 2 diabetes, insulin resistance, Adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blaeberry concentrated caspule | Active comparator | Dietary Supplement: Mirtoselect30 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/) |
| Placebo capsules containing lactose | Placebo comparator | Dietary Supplement: Mirtoselect30 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- Chronic illness, including:
- Alcohol or any other substance abuse,
- Eating disorders,
- Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),
- Skin conditions on the abdomen,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtoselectMale 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. | Dietary supplement | Blaeberry concentrated caspule, Placebo capsules containing lactose |
Primary outcome
Oral Glucose Tolerance Test
Time frame: Day 0 and 21 days post intervention
Change in Oral Glucose Tolerance following intervention
1 secondary outcome
Fasting blood glucose/insulin
Time frame: Day 0, 7, 14, and 21 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 16979328Martineau 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.
- Background: PubMed 17533652Zafra-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.
- Background: PubMed 17265471Lau 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.
- Background: PubMed 19515743DeFuria 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.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Hoggard, PhD principal investigator
University of Aberdeen Rowett Institute of Nutrition and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirtoselect in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Glucose Tolerance Test (time frame: Day 0 and 21 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180712, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.