NCT02629952

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

6.1 years

First QC Date

December 3, 2015

Last Update Submit

April 4, 2021

Conditions

Type 2 Diabetes

Keywords

glucose tolerancetype 2 diabetesblueberry tea

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (8)

  • Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.

    4 weeks.

  • Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.

    4 weeks

  • Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.

    4 weeks

  • Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..

    4 weeks

  • Fasting serum electrolytes (Na, K, Cl, HCO3).

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Blueberry Tea

EXPERIMENTAL

3 cups of blueberry tea per day x 4 weeks

Other: Blueberry Tea

No Treatment

NO INTERVENTION

No Treatment

Interventions

Blueberry TeaOTHER

Blueberry Tea

Blueberry Tea

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menzies Institute for Medical Research

Hobart, Tasmania, 7000, Australia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 19515743BACKGROUND

  • 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.

    PMID: 16979328BACKGROUND

  • 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.

    PMID: 20724487BACKGROUND

  • 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.

    PMID: 20515642BACKGROUND

  • 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.

    PMID: 15002064BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michelle A Keske, PhD

    Menzies Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle A Keske, PhD

CONTACT

+61 3 6226 2669Michelle.Keske@deakin.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 15, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)