Health, SubjectiveNCT06488326
Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
A study testing Mulberry leaf extract 6 mg capsule, Mulberry leaf extract 12 mg capsule and Mulberry leaf extract 18 mg capsule in people with Health, Subjective, run by Chulalongkorn University.
Trial summary
Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Mulberry leaf extract 6 mg capsule, Mulberry leaf extract 12 mg capsule and Mulberry leaf extract 18 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 25 Feb 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- No diabetes mellitus
- Have blood glucose less than 126 mg/dL
- Wiling to attend the study
Who cannot join
- Take steroids, psychiatric medicine, thiazide diuretic medicine, and beta blocker medicine within 2 weeks before starting of the study
- Take dietary supplement, herbal substance, and weight-loss medicine within 2 weeks before starting of the study
- Uncontrolled diseases
- History of gastrointestinal tract surgery
- Liver and Kidney diseases
- Pregnancy and lactation
About this study
Official title: Effect of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Then, they will take 1 capsule of the sample one time. After taking the sample for 30 minutes, they will take 50 g of sucrose in 250 ml of water in 5 minutes. Then, they will be tested blood glucose levels (taken from the fingertips) at 30, 60, 90, and 120 minutes.
- Conditions
- Health, Subjective
- Being tested
- Mulberry leaf extract 6 mg capsule, Mulberry leaf extract 12 mg capsule, Mulberry leaf extract 18 mg capsule, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry leaf extract 6 mg capsuleDrug
Take one capsule of the sample one time.
Mulberry leaf extract 12 mg capsuleDrug
Take one capsule of the sample one time.
Mulberry leaf extract 18 mg capsuleDrug
Take one capsule of the sample one time.
Placebo capsuleDrug
Take one capsule of the sample one time.
| Study group | Role | What they receive |
|---|---|---|
| Mulberry leaf extract 6 mg capsule | Experimental | Take one capsule of the sample one time. Receives: Drug: Mulberry leaf extract 6 mg capsule |
| Mulberry leaf extract 12 mg capsule | Experimental | Take one capsule of the sample one time. Receives: Drug: Mulberry leaf extract 12 mg capsule |
| Mulberry leaf extract 18 mg capsule | Experimental | Take one capsule of the sample one time. Receives: Drug: Mulberry leaf extract 18 mg capsule |
| Placebo capsule | Placebo comparator | Take one capsule of the sample one time. Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Volunteers will be measured the blood glucose using blood glucose meter and strip (accuchek) before and after taking the sample for 30, 60, 90, and 120 minutes.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Mae Fah Luang University
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488326
- Sponsor's protocol ID
- EC23188-20
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06488326
- Acronym / sponsor ID
- EC23188-20
- Conditions
- Health, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Mae Fah Luang University
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Then, they will take 1 capsule of the sample one time. After taking the sample for 30 minutes, they will take 50 g of sucrose in 250 ml of water in 5 minutes. Then, they will be tested blood glucose levels (taken from the fingertips) at 30, 60, 90, and 120 minutes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mulberry leaf extract 6 mg capsule | Experimental | Drug: Mulberry leaf extract 6 mg capsuleTake one capsule of the sample one time. |
| Mulberry leaf extract 12 mg capsule | Experimental | Drug: Mulberry leaf extract 12 mg capsuleTake one capsule of the sample one time. |
| Mulberry leaf extract 18 mg capsule | Experimental | Drug: Mulberry leaf extract 18 mg capsuleTake one capsule of the sample one time. |
| Placebo capsule | Placebo comparator | Drug: Placebo capsuleTake one capsule of the sample one time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- No diabetes mellitus
- Have blood glucose less than 126 mg/dL
- Wiling to attend the study
Key exclusion criteria (6 listed)
- Take steroids, psychiatric medicine, thiazide diuretic medicine, and beta blocker medicine within 2 weeks before starting of the study
- Take dietary supplement, herbal substance, and weight-loss medicine within 2 weeks before starting of the study
- Uncontrolled diseases
- History of gastrointestinal tract surgery
- Liver and Kidney diseases
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 extract 6 mg capsuleTake one capsule of the sample one time. | Drug | Mulberry leaf extract 6 mg capsule |
| Mulberry leaf extract 12 mg capsuleTake one capsule of the sample one time. | Drug | Mulberry leaf extract 12 mg capsule |
| Mulberry leaf extract 18 mg capsuleTake one capsule of the sample one time. | Drug | Mulberry leaf extract 18 mg capsule |
| Placebo capsuleTake one capsule of the sample one time. | Drug | Placebo capsule |
Primary outcome
Blood glucose
Time frame: 120 minutes
Volunteers will be measured the blood glucose using blood glucose meter and strip (accuchek) before and after taking the sample for 30, 60, 90, and 120 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Related trials for Health, Subjective
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Recruiting
Florida Community-Engaged Research Alliance (FL-CEAL)
Health, Subjective
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 Mulberry leaf extract 6 mg capsule, Mulberry leaf extract 12 mg capsule and Mulberry leaf extract 18 mg capsule in people with Health, Subjective, run by Chulalongkorn University.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. 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?
Results are not available in the source record.
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 (time frame: 120 minutes). 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 5 Jul 2024.