NCT03330366

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

October 30, 2017

Last Update Submit

November 19, 2018

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Changes of blood glucose during OGTT

    Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention

    8 weeks

Secondary Outcomes (3)

  • Changes of blood insulin

    8 week

  • Changes of C-peptide

    8 week

  • Changes of HbA1c

    8 week

Study Arms (2)

Allium hookeri extract

EXPERIMENTAL

take two capsules per day (486 mg/day) for 8 weeks

Dietary Supplement: Allium hookeri extract

Placebo

PLACEBO COMPARATOR

take two capsules per day for 8 weeks

Dietary Supplement: Placebo

Interventions

Allium hookeri extractDIETARY_SUPPLEMENT

take two capsules per day (486 mg/day) for 8 weeks

Also known as: AH
Allium hookeri extract
PlaceboDIETARY_SUPPLEMENT

take two capsules per day

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting glucose 100\~126 mg/dl

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32631388DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

November 24, 2015

Primary Completion

July 8, 2016

Study Completion

March 31, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11