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

This study has been completed.
Sponsor:
Collaborator:
Agricultural Producers' Cooperative Corporation Shinpo-en
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT02023320
First received: December 17, 2013
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention
Prediabetes
Dietary Supplement: Low dose of blueberry dry powder
Dietary Supplement: High dose of blueberry dry powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Change in fasting plasma glucose from baseline [ Time Frame: Every 6 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Change in HbA1c from baseline [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glycoalbumin from baseline [ Time Frame: Every 6 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Change in fasting insulin from baseline [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
    HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405

  • Change in serum C-peptide from baseline [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT02023320     History of Changes
Other Study ID Numbers: eki-842
Study First Received: December 17, 2013
Last Updated: August 7, 2014
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014