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Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

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ClinicalTrials.gov Identifier: NCT02023320
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : August 11, 2014
Sponsor:
Collaborator:
Agricultural Producers' Cooperative Corporation Shinpo-en
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University

Brief Summary:
The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.

Condition or disease Intervention/treatment
Prediabetes Dietary Supplement: Low dose of blueberry dry powder Dietary Supplement: High dose of blueberry dry powder

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes
Study Start Date : November 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low dose of blueberry dry powder
0.5 g blueberry dry powder, twice a day for 12 weeks
Dietary Supplement: Low dose of blueberry dry powder
Experimental: High dose of blueberry dry powder
5.0 g blueberry dry powder, twice a day for 12 weeks
Dietary Supplement: High dose of blueberry dry powder



Primary Outcome Measures :
  1. Change in fasting plasma glucose from baseline [ Time Frame: Every 6 weeks (Overall 12 weeks) ]
  2. Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline [ Time Frame: Weeks 0 and 12 ]
  3. Change in HbA1c from baseline [ Time Frame: Weeks 0 and 12 ]

Secondary Outcome Measures :
  1. Change in glycoalbumin from baseline [ Time Frame: Every 6 weeks (Overall 12 weeks) ]
  2. Change in fasting insulin from baseline [ Time Frame: Weeks 0 and 12 ]
  3. Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline [ Time Frame: Weeks 0 and 12 ]
    HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405

  4. Change in serum C-peptide from baseline [ Time Frame: Weeks 0 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

  • Taking anti-diabetic drugs
  • Taking drugs or functional food that may affect blood glucose level
  • Fruit allergy
  • Pregnant or nursing a child
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023320


Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Agricultural Producers' Cooperative Corporation Shinpo-en
Investigators
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT02023320     History of Changes
Other Study ID Numbers: eki-842
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia