Back to resultsEffects of Allium Hookeri on Blood Glucose
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allium hookeri extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Allium hookeri extract
Placebo
Arm Description
take two capsules per day (486 mg/day) for 8 weeks
take two capsules per day for 8 weeks
Outcomes
Primary Outcome Measures
Changes of blood glucose during OGTT
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention
Secondary Outcome Measures
Changes of blood insulin
Changes of blood insulin were assessed before and after the intervention
Changes of C-peptide
Changes of C-peptide were assessed before and after the intervention
Changes of HbA1c
Changes of HbA1c were assessed before and after the intervention
Full Information
NCT ID
NCT03330366
First Posted
October 30, 2017
Last Updated
November 19, 2018
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03330366
Brief Title
Effects of Allium Hookeri on Blood Glucose
Official Title
An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
July 8, 2016 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allium hookeri extract
Arm Type
Experimental
Arm Description
take two capsules per day (486 mg/day) for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
take two capsules per day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Allium hookeri extract
Other Intervention Name(s)
AH
Intervention Description
take two capsules per day (486 mg/day) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
take two capsules per day
Primary Outcome Measure Information:
Title
Changes of blood glucose during OGTT
Description
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes of blood insulin
Description
Changes of blood insulin were assessed before and after the intervention
Time Frame
8 week
Title
Changes of C-peptide
Description
Changes of C-peptide were assessed before and after the intervention
Time Frame
8 week
Title
Changes of HbA1c
Description
Changes of HbA1c were assessed before and after the intervention
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
32631388
Citation
Park SH, Bae UJ, Choi EK, Jung SJ, Lee SH, Yang JH, Kim YS, Jeong DY, Kim HJ, Park BH, Chae SW. A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes. BMC Complement Med Ther. 2020 Jul 6;20(1):211. doi: 10.1186/s12906-020-03005-3.
Results Reference
derived
Learn more about this trial
Effects of Allium Hookeri on Blood Glucose
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