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Completed

NCT Number: NCT02213549

Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder

This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.

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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 105-125 mg/dL

Exclusion criteria

  • Taking anti-diabetic drugs
  • Taking drugs or functional food that may affect blood glucose level
  • 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
  • History of severe disease and/or major surgery

Treatment and study plan

Placebo

Dietary Supplement

Ume paste and ginger 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

Secondary outcomes

  1. Change in HbA1c from baseline

    Time frame: Weeks 0 and 12

  2. Change in glycoalbumin from baseline

    Time frame: Weeks 0 and 12

  3. Change in fasting insulin from baseline

    Time frame: Weeks 0 and 12

  4. 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

  5. Change in serum total cholesterol from baseline

    Time frame: Every 6 weeks (Overall 12 weeks)

  6. Change in serum LDL cholesterol from baseline

    Time frame: Every 6 weeks (Overall 12 weeks)

  7. Change in serum HDL cholesterol from baseline

    Time frame: Every 6 weeks (Overall 12 weeks)

  8. Change in serum triglyceride from baseline

    Time frame: Every 6 weeks (Overall 12 weeks)

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • KAWAMOTO FOODS CO., LTD.

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 11, 2014
Registry last updated
Mar 19, 2015

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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