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Completed

NCT Number: NCT02023320

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose of blueberry dry powder

Dietary Supplement

High dose of blueberry dry powder

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Agricultural Producers' Cooperative Corporation Shinpo-en

Registry information

Official study title

A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 30, 2013
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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