Effects of Allium Hookeri on Blood Glucose

November 19, 2018 updated by: Soo-Wan Chae, Chonbuk National University Hospital

An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • AH
Placebo Comparator: Placebo
take two capsules per day for 8 weeks
Dietary supplement: Placebo
take two capsules per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of blood insulin
Time Frame: 8 week
Changes of blood insulin were assessed before and after the intervention
8 week
Changes of C-peptide
Time Frame: 8 week
Changes of C-peptide were assessed before and after the intervention
8 week
Changes of HbA1c
Time Frame: 8 week
Changes of HbA1c were assessed before and after the intervention
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2015

Primary Completion (Actual)

July 8, 2016

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCF2_2015_AH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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