Type 2 DiabetesNCT02629952
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
A study testing Blueberry Tea in people with Type 2 Diabetes, run by Menzies Institute for Medical Research at 1 site in Australia.
Trial summary
Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show great potential as nutraceuticals for the treatment of various diseases such as type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Blueberry Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2015to Dec 2021
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75 years.
- Normal to overweight (BMI 19-35 kg/m2).
- On lifestyle or metformin only diabetes treatment.
- Normotensive (seated brachial blood pressure <160/100 mmHg).
- No history of T2D (e.g. fasting plasma glucose <7.0mM); or with clinically diagnosed T2D on metformin or lifestyle intervention only (e.g. fasting plasma glucose ≥7.0mM, HbA1c).
- Willing to drink blueberry tea for 4 weeks (3 times per day with meals).
Who cannot join
- Age <18 yrs or >76 yrs
- Morbidly obese with a BMI ≥36 kg/m2
- Not on lifestyle and/or metformin only treatment for diabetes (e.g. insulin injections, sulphonylureas).
- History of myocardial infarction or stroke
- History of malignancy within past 5 years (except for non-melanoma skin cancers)
- Current smoker
Show all 13Show fewer
- History of severe liver disease
- History of drug or alcohol abuse
- Elective major surgery during the course of the study
- Pregnancy/lactation
- Currently consuming (or have regularly consumed in the past 2 months) blueberry tea, or supplements containing blueberries, blueberry leaves, raspberry leaves, spearmint or cinnamon.
- Participation or intention to participate in another clinical research study during the study period.
- Not willing to consume blueberry tea for 4 weeks.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Menzies Institute for Medical Research
Hobart, Tasmania, 7000
Michelle A Keske, PhD, +61 3 6226 2669, Michelle.Keske@deakin.edu.au
Keske
About this study
Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show great potential as nutraceuticals for the treatment of various diseases such as type 2 diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood lipids, reduce oxidative stress and improve vascular function. For these reasons we recently investigated the effects of daily consumption of locally produced blueberry tea and demonstrated that this could partially restore insulin sensitivity in an animal model. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.
Read the detailed description
Current treatments for T2D are limited, have unwanted side effects, and lose effectiveness over time. There is a growing public interest in the use of complementary and alternative approaches for treating insulin resistance and T2D. Blueberries, blueberry leaves and cinnamon have each been reported to improve insulin sensitivity or insulin action. Blueberry Boost™ is a locally produced Blueberry Tea and is a proprietary blend of dried blueberries (37% wt/wt), blueberry leaves, raspberry leaves, spearmint leaves and cinnamon.
It is well established that improving glycemic control is important for managing insulin resistance and T2D and the associated vascular pathologies that directly contribute to end-organ damage (microvascular disease), hypertension and cardiovascular disease (stroke, heart attack and heart failure). We have recently demonstrated that a unique blueberry tea blend fully restores the vascular insulin sensitivity in muscle of the high-fat fed insulin-resistant rat model and is associated with substantial improvements in muscle glucose uptake and whole body insulin sensitivity. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.
Aim: Determine whether chronic consumption (4 weeks) of blueberry tea can improve metabolic and vascular health in people with and without T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- Blueberry Tea
- Keywords
- glucose tolerance, type 2 diabetes, blueberry tea
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry TeaOther
Blueberry Tea
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Tea | Experimental | 3 cups of blueberry tea per day x 4 weeks Receives: Other: Blueberry Tea |
| No Treatment | No intervention | No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.
Oral glucose tolerance test (75g glucose) measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design). Blood glucose and plasma insulin levels measured at 0, 15, 30, 60, 90 and 120 min following consumption of glucose load.
Measured: 4 weeks
Secondary outcomes (8)
Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.
HbA1c levels measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks.
Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.
Fasting serum lipids (cholesterol, HDL, LDL,triglycerides) measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.
Fasting serum pro-inflammatory cytokines (IL-6, IL-1b, CRP, TNFa) assessed by ELISA will be measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..
Fasting serum albumin levels measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Fasting serum electrolytes (Na, K, Cl, HCO3).
Fasting serum electrolytes (Na, K, Cl, HCO3) measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.
Blood Pressure (central and brachial blood pressure) will be measured by Mobil-O-Graph and assessed on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.
Augmentation index will be measured by Mobil-O-Graph and assessed on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.
Large artery stiffness will be measured by Mobil-O-Graph and assessed on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies Institute for Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Keske, Menzies Institute for Medical Research
- Investigators
- Michelle A Keske, PhD, Principal investigator, Menzies Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629952
- Sponsor's protocol ID
- H0014873
- Status last verified
- Apr 2021
- First submitted
- 3 Dec 2015
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19515743Martineau 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 16979328Stull AJ, Cash KC, Johnson WD, Champagne CM, Cefalu WT. Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women. J Nutr. 2010 Oct;140(10):1764-8. doi: 10.3945/jn.110.125336. Epub 2010 Aug 19.
PubMed 20724487Couturier K, Batandier C, Awada M, Hininger-Favier I, Canini F, Anderson RA, Leverve X, Roussel AM. Cinnamon improves insulin sensitivity and alters the body composition in an animal model of the metabolic syndrome. Arch Biochem Biophys. 2010 Sep 1;501(1):158-61. doi: 10.1016/j.abb.2010.05.032. Epub 2010 May 31.
PubMed 20515642Qin B, Nagasaki M, Ren M, Bajotto G, Oshida Y, Sato Y. Cinnamon extract prevents the insulin resistance induced by a high-fructose diet. Horm Metab Res. 2004 Feb;36(2):119-25. doi: 10.1055/s-2004-814223.
PubMed 15002064
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02629952
- Acronym / sponsor ID
- H0014873
- Conditions
- Type 2 Diabetes
- Keywords
- glucose tolerance, type 2 diabetes, blueberry tea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Menzies Institute for Medical ResearchUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Dec 2015 (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.
Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show great potential as nutraceuticals for the treatment of various diseases such as type 2 diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood lipids, reduce oxidative stress and improve vascular function. For these reasons we recently investigated the effects of daily consumption of locally produced blueberry tea and demonstrated that this could partially restore insulin sensitivity in an animal model. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.
Detailed description
Current treatments for T2D are limited, have unwanted side effects, and lose effectiveness over time. There is a growing public interest in the use of complementary and alternative approaches for treating insulin resistance and T2D. Blueberries, blueberry leaves and cinnamon have each been reported to improve insulin sensitivity or insulin action. Blueberry Boost™ is a locally produced Blueberry Tea and is a proprietary blend of dried blueberries (37% wt/wt), blueberry leaves, raspberry leaves, spearmint leaves and cinnamon.
It is well established that improving glycemic control is important for managing insulin resistance and T2D and the associated vascular pathologies that directly contribute to end-organ damage (microvascular disease), hypertension and cardiovascular disease (stroke, heart attack and heart failure). We have recently demonstrated that a unique blueberry tea blend fully restores the vascular insulin sensitivity in muscle of the high-fat fed insulin-resistant rat model and is associated with substantial improvements in muscle glucose uptake and whole body insulin sensitivity. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.
Aim: Determine whether chronic consumption (4 weeks) of blueberry tea can improve metabolic and vascular health in people with and without T2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Tea | Experimental | Other: Blueberry Tea3 cups of blueberry tea per day x 4 weeks |
| No Treatment | No intervention | –No Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years.
- Normal to overweight (BMI 19-35 kg/m2).
- On lifestyle or metformin only diabetes treatment.
- Normotensive (seated brachial blood pressure <160/100 mmHg).
- No history of T2D (e.g. fasting plasma glucose <7.0mM); or with clinically diagnosed T2D on metformin or lifestyle intervention only (e.g. fasting plasma glucose ≥7.0mM, HbA1c).
Key exclusion criteria (13 listed)
- Age <18 yrs or >76 yrs
- Morbidly obese with a BMI ≥36 kg/m2
- Not on lifestyle and/or metformin only treatment for diabetes (e.g. insulin injections, sulphonylureas).
- History of myocardial infarction or stroke
- History of malignancy within past 5 years (except for non-melanoma skin cancers)
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 |
|---|---|---|
| Blueberry TeaBlueberry Tea | Other | Blueberry Tea |
Primary outcome
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Oral glucose tolerance test (75g glucose) measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design). Blood glucose and plasma insulin levels measured at 0, 15, 30, 60, 90 and 120 min following consumption of glucose load.
8 secondary outcomes
Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks.
Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..
Time frame: 4 weeks
Fasting serum electrolytes (Na, K, Cl, HCO3).
Time frame: 4 weeks
Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- 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.
- 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 20724487Stull AJ, Cash KC, Johnson WD, Champagne CM, Cefalu WT. Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women. J Nutr. 2010 Oct;140(10):1764-8. doi: 10.3945/jn.110.125336. Epub 2010 Aug 19.
- Background: PubMed 20515642Couturier K, Batandier C, Awada M, Hininger-Favier I, Canini F, Anderson RA, Leverve X, Roussel AM. Cinnamon improves insulin sensitivity and alters the body composition in an animal model of the metabolic syndrome. Arch Biochem Biophys. 2010 Sep 1;501(1):158-61. doi: 10.1016/j.abb.2010.05.032. Epub 2010 May 31.
- Background: PubMed 15002064Qin B, Nagasaki M, Ren M, Bajotto G, Oshida Y, Sato Y. Cinnamon extract prevents the insulin resistance induced by a high-fructose diet. Horm Metab Res. 2004 Feb;36(2):119-25. doi: 10.1055/s-2004-814223.
- Individual participant dataSharing planned: No
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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.
Michelle A Keske, PhD principal investigator
Menzies Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Tea in people with Type 2 Diabetes, run by Menzies Institute for Medical Research at 1 site in Australia.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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 Australia. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle A Keske, PhD (+61 3 6226 2669, Michelle.Keske@deakin.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea. (time frame: 4 weeks). 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 NCT02629952, which also lists 5 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 6 Apr 2021.