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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02629952
Registration number
NCT02629952
Ethics application status
Date submitted
3/12/2015
Date registered
15/12/2015
Titles & IDs
Public title
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
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Scientific title
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
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Secondary ID [1]
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H0014873
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Blueberry Tea
Experimental: Blueberry Tea - 3 cups of blueberry tea per day x 4 weeks
No intervention: No Treatment - No Treatment
Other interventions: Blueberry Tea
Blueberry Tea
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.
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Assessment method [1]
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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.
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Timepoint [1]
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4 weeks
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Secondary outcome [1]
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Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.
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Assessment method [1]
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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).
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Timepoint [1]
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4 weeks.
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Secondary outcome [2]
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Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.
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Assessment method [2]
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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).
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Timepoint [2]
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4 weeks
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Secondary outcome [3]
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Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.
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Assessment method [3]
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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).
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Timepoint [3]
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4 weeks
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Secondary outcome [4]
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Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..
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Assessment method [4]
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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).
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Timepoint [4]
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4 weeks
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Secondary outcome [5]
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Fasting serum electrolytes (Na, K, Cl, HCO3).
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Assessment method [5]
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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).
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.
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Assessment method [6]
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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).
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Timepoint [6]
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4 weeks
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Secondary outcome [7]
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Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.
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Assessment method [7]
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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).
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Timepoint [7]
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4 weeks
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Secondary outcome [8]
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Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.
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Assessment method [8]
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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).
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Timepoint [8]
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4 weeks
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Eligibility
Key inclusion criteria
* 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).
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2021
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
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Menzies Institute for Medical Research - Hobart
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Recruitment postcode(s) [1]
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7000 - Hobart
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Funding & Sponsors
Primary sponsor type
Other
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Name
Menzies Institute for Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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). 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.
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Trial website
https://clinicaltrials.gov/study/NCT02629952
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Trial related presentations / 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. 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. Stull 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. Couturier 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. Qin 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.
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Public notes
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Contacts
Principal investigator
Name
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Michelle A Keske, PhD
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Address
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Menzies Institute for Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Michelle A Keske, PhD
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Address
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Country
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Phone
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+61 3 6226 2669
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02629952