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Effects of Allium Hookeri on Blood Glucose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330366
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Brief Summary:
The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.

Condition or disease Intervention/treatment Phase
PreDiabetes Dietary Supplement: Allium hookeri extract Dietary Supplement: Placebo Not Applicable

Detailed Description:
Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects
Actual Study Start Date : November 24, 2015
Actual Primary Completion Date : July 8, 2016
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Allium hookeri extract
take two capsules per day (486 mg/day) for 8 weeks
Dietary Supplement: Allium hookeri extract
take two capsules per day (486 mg/day) for 8 weeks
Other Name: AH

Placebo Comparator: Placebo
take two capsules per day for 8 weeks
Dietary Supplement: Placebo
take two capsules per day




Primary Outcome Measures :
  1. Changes of blood glucose during OGTT [ Time Frame: 8 weeks ]
    Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention


Secondary Outcome Measures :
  1. Changes of blood insulin [ Time Frame: 8 week ]
    Changes of blood insulin were assessed before and after the intervention

  2. Changes of C-peptide [ Time Frame: 8 week ]
    Changes of C-peptide were assessed before and after the intervention

  3. Changes of HbA1c [ Time Frame: 8 week ]
    Changes of HbA1c were assessed before and after the intervention



Information from the National Library of Medicine

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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 glucose 100~126 mg/dl

Exclusion Criteria:

  • Significant variation in weight (more 10%) in the past 3 months
  • Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months
  • Type 1 diabetes or HbA1c>9.0%
  • Cardiovascular disease
  • Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts
  • Pregnancy or breast feeding
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03330366    
Other Study ID Numbers: CTCF2_2015_AH
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases