Prediabetic StateNCT01385865
Effect of Mulberry Leaf Extract on Blood Glucose
A study testing Mulberry leaf extract in people with Prediabetic State, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Mulberry leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Oct 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: over 20 years
- Fasting glucose: 100mg/dl ≤ ~ ≤ 125mg/dl
- HbA1c: < 6.5%
Who cannot join
- Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit
- Subject who has taken part in other clinical trials in 30 days prior to screening visit
- Subject who is pregnant or breast feeding
- Subject who lost body weight over 4 kg in 30 days prior to screening visit
- Alcoholic
- Heavy smoker (≥ 20 cigarettes/day)
- Subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmHg), diabetes (fasting blood glucose ≥ 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease
- Subject who has an allergy to the ingredients of study product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.
Read the detailed description
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.
- Conditions
- Prediabetic State
- Being tested
- Mulberry leaf 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.
Mulberry leaf extractDietary supplement
18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks
PlaceboDietary supplement
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mulberry leaf extract | Experimental | Not described Receives: Dietary Supplement: Mulberry leaf extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose change with meal tolerance test
Measured: 0wk
Secondary outcomes (10)
Blood glucose change with meal tolerance test
Measured: 4wk
Insulin and C-peptide changes with meal tolerance test
Measured: 0, 4 wk
Fasting blood glucose
Measured: 0, 4 wk
Insulin
Measured: 0, 4wk
C-peptide
Measured: 0, 4wk
Glycated albumin
Measured: 0, 4wk
High sensitivity C-reactive protein
Measured: 0, 4wk
Oxidized low-density lipoprotein
Measured: 0, 4wk
Malondialdehyde
Measured: 0, 4wk
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)
Measured: 0, 4wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Collaborators
- CHA University, Ministry of Knowledge Economy, Korea
- Responsible party
- Principal investigator, Oran Kwon, Ewha Womans University
- Investigators
- Oran Kwon, Ph.D, Principal investigator, Ewha Womans UniversitySung Won Kwon, MD, Principal investigator, CHA UniversitySeok Won Park, MD, Principal investigator, CHA UniversityMoon Jong Kim, MD, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385865
- Sponsor's protocol ID
- MLE_Biofood_2
- Status last verified
- Oct 2011
- First submitted
- 28 Jun 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose
- ClinicalTrials.gov ID
- NCT01385865
- Acronym / sponsor ID
- MLE_Biofood_2
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Collaborators
- CHA University, Ministry of Knowledge Economy, Korea
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Jun 2011 (estimated)
- 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 purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.
Detailed description
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulberry leaf extract | Experimental | Dietary Supplement: Mulberry leaf extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: over 20 years
- Fasting glucose: 100mg/dl ≤ ~ ≤ 125mg/dl
- HbA1c: < 6.5%
Key exclusion criteria (8 listed)
- Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit
- Subject who has taken part in other clinical trials in 30 days prior to screening visit
- Subject who is pregnant or breast feeding
- Subject who lost body weight over 4 kg in 30 days prior to screening visit
- Alcoholic
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 |
|---|---|---|
| Mulberry leaf extract18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks | Dietary supplement | Mulberry leaf extract |
| Placebo18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks | Dietary supplement | Placebo |
Primary outcome
Blood glucose change with meal tolerance test
Time frame: 0wk
10 secondary outcomes
Blood glucose change with meal tolerance test
Time frame: 4wk
Insulin and C-peptide changes with meal tolerance test
Time frame: 0, 4 wk
Fasting blood glucose
Time frame: 0, 4 wk
Insulin
Time frame: 0, 4wk
C-peptide
Time frame: 0, 4wk
Glycated albumin
Time frame: 0, 4wk
High sensitivity C-reactive protein
Time frame: 0, 4wk
Oxidized low-density lipoprotein
Time frame: 0, 4wk
Malondialdehyde
Time frame: 0, 4wk
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)
Time frame: 0, 4wk
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 28 Oct 2011.
Related trials for Prediabetic State
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
Oran Kwon, Ph.D principal investigator
Ewha Womans University
Sung Won Kwon, MD principal investigator
CHA University
Seok Won Park, MD principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry leaf extract in people with Prediabetic State, run by Ewha Womans University at 1 site in South Korea.
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 3 inclusion and 8 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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Blood glucose change with meal tolerance test (time frame: 0wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2011.