Effects of Allium Hookeri on Blood Glucose

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330366
• Other study ID #: CTCF2_2015_AH
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: November 2018
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Allium hookeri extract
take two capsules per day (486 mg/day) for 8 weeks
• Placebo
take two capsules per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of blood glucose during OGTT	Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention	8 weeks
Secondary	Changes of blood insulin	Changes of blood insulin were assessed before and after the intervention	8 week
Secondary	Changes of C-peptide	Changes of C-peptide were assessed before and after the intervention	8 week
Secondary	Changes of HbA1c	Changes of HbA1c were assessed before and after the intervention	8 week