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Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Blueberry Tea
Sponsored by
Menzies Institute for Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring glucose tolerance, type 2 diabetes, blueberry tea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

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.

Sites / Locations

  • Menzies Institute for Medical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Blueberry Tea

No Treatment

Arm Description

3 cups of blueberry tea per day x 4 weeks

No Treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
December 3, 2015
Last Updated
April 4, 2021
Sponsor
Menzies Institute for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02629952
Brief Title
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
Official Title
Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menzies Institute for Medical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
glucose tolerance, type 2 diabetes, blueberry tea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blueberry Tea
Arm Type
Experimental
Arm Description
3 cups of blueberry tea per day x 4 weeks
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
No Treatment
Intervention Type
Other
Intervention Name(s)
Blueberry Tea
Intervention Description
Blueberry Tea
Primary Outcome Measure Information:
Title
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks.
Title
Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks
Title
Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks
Title
Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..
Description
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).
Time Frame
4 weeks
Title
Fasting serum electrolytes (Na, K, Cl, HCO3).
Description
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).
Time Frame
4 weeks
Title
Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks
Title
Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks
Title
Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle A Keske, PhD
Phone
+61 3 6226 2669
Email
Michelle.Keske@deakin.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle A Keske, PhD
Organizational Affiliation
Menzies Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menzies Institute for Medical Research
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle A Keske, PhD
Phone
+61 3 6226 2669
Email
Michelle.Keske@deakin.edu.au
First Name & Middle Initial & Last Name & Degree
Keske

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19515743
Citation
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.
Results Reference
background
PubMed Identifier
16979328
Citation
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.
Results Reference
background
PubMed Identifier
20724487
Citation
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.
Results Reference
background
PubMed Identifier
20515642
Citation
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.
Results Reference
background
PubMed Identifier
15002064
Citation
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.
Results Reference
background

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Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes

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