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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
Scientific title
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
Secondary ID [1] 0 0
H0014873
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.
Timepoint [1] 0 0
4 weeks.
Secondary outcome [2] 0 0
Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Fasting serum electrolytes (Na, K, Cl, HCO3).
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.
Timepoint [8] 0 0
4 weeks

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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Institute for Medical Research - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies Institute for Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michelle A Keske, PhD
Address 0 0
Menzies Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle A Keske, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 6226 2669
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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