PreDiabetesNCT03330366
Effects of Allium Hookeri on Blood Glucose
A study testing Allium hookeri extract in people with PreDiabetes, run by Chonbuk National University Hospital.
Trial summary
The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Allium hookeri extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2015to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting glucose 100~126 mg/dl
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Allium hookeri extract, Placebo
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium hookeri extractDietary supplement
Also called AH
take two capsules per day (486 mg/day) for 8 weeks
PlaceboDietary supplement
take two capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Allium hookeri extract | Experimental | take two capsules per day (486 mg/day) for 8 weeks Receives: Dietary Supplement: Allium hookeri extract |
| Placebo | Placebo comparator | take two capsules per day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose during OGTT
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention
Measured: 8 weeks
Secondary outcomes (3)
Changes of blood insulin
Changes of blood insulin were assessed before and after the intervention
Measured: 8 week
Changes of C-peptide
Changes of C-peptide were assessed before and after the intervention
Measured: 8 week
Changes of HbA1c
Changes of HbA1c were assessed before and after the intervention
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Nov 2015
- Primary completion8 Jul 2016
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330366
- Sponsor's protocol ID
- CTCF2_2015_AH
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32631388
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects
- ClinicalTrials.gov ID
- NCT03330366
- Acronym / sponsor ID
- CTCF2_2015_AH
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allium hookeri extract | Experimental | Dietary Supplement: Allium hookeri extracttake two capsules per day (486 mg/day) for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebotake two capsules per day for 8 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting glucose 100~126 mg/dl
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allium hookeri extractAlso: AHtake two capsules per day (486 mg/day) for 8 weeks | Dietary supplement | Allium hookeri extract |
| Placebotake two capsules per day | Dietary supplement | Placebo |
Primary outcome
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
3 secondary outcomes
Changes of blood insulin
Time frame: 8 week
Changes of C-peptide
Time frame: 8 week
Changes of HbA1c
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 32631388Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Allium hookeri extract in people with PreDiabetes, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose during OGTT (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.