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

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ClinicalTrials.gov Identifier: NCT02213549
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
KAWAMOTO FOODS CO., LTD.
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University

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

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: Placebo Dietary Supplement: Ume paste and ginger powder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Placebo Comparator: Placebo
3 placebo capsules/day for 12 weeks
Dietary Supplement: Placebo
Experimental: Ume paste and ginger powder
3 experimental capsules/day for 12 weeks.
Dietary Supplement: Ume paste and ginger 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 ]

Secondary Outcome Measures :
  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) ]


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

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

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): NCT02213549


Locations
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Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
KAWAMOTO FOODS CO., LTD.
Investigators
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Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University

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Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT02213549     History of Changes
Other Study ID Numbers: eki-996
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases