ObesityNCT04691219
Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
A study testing Mulberry leaves powder in people with Obesity and Type 2 Diabetes Mellitus, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A 12-week, open-label, randomized, controlled trial investigating effect of mulberry leaves plus lifestyle intervention on glycemic control compare with lifestyle intervention alone in patients with obesity and patients with type 2 diabetes (T2DM) Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Mulberry leaves powder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 26 May 2019to 19 Feb 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men age 20-65 years
- Have 1 of 3 characteristics as follows;
- Non-diabetic obese patients (BMI ≥25 kg/m2)
- Patients with T2DM: drug naïve and newly diagnosed within 6 months before study enrollment
- Patients with T2DM: inadequate control (A1c ≥7%, but not >8%) with metformin therapy (>1,000 mg/day) alone at least 3 months before study enrollment
- Well communicate in the Thai language
Who cannot join
- Allergy to mulberry leaves products
- FPG ≥180 mg/dL
- A1c >8%
- AST and ALT >40 U/L
- Cr <0.6 or >1.2 mg/dL
- BUN >20 mg/dL
Show all 12Show fewer
- Existing or having history of gastrointestinal surgery or abnormal conditions affecting digestion and intestinal absorption
- Existing or having history of hematological disorders, thyroid diseases, CVD, ischemic stroke, CKD, or other uncontrolled and life-threatening conditions
- Presence of significant diabetic complications
- Taking drugs, supplements, and herbs affecting blood glucose level: corticosteroids, second-generation antipsychotics, niacin, thiazide diuretics, and ß-blockers, within 1 month before study enrollment
- Taking unnecessary drugs, supplements, and herbs affecting lipid level within 1 month before study enrollment
- Women during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
A 12-week, open-label, randomized, controlled trial investigating effect of mulberry leaves plus lifestyle intervention on glycemic control compare with lifestyle intervention alone in patients with obesity and patients with type 2 diabetes (T2DM)
Read the detailed description
Diabetes remains a common leading cause of morbidity and mortality among population worldwide over decades. Obesity, a crucial risk factors for developing T2DM, commonly exists with insulin resistance and impaired beta-cell function. Early management in individuals at high risk of T2DM should be therefore considered for preventing or delaying the progression of diabetes and diabetic complications.
Since 1-deoxynojirimycin (DNJ), the major antihyperglycemic compound of mulberry leaves, inhibits alpha-glucosidase activities, ingestion of mulberry leaves results in the suppression of postprandial hyperglycemia. Long-term effects of mulberry leaves on glycemic profiles have been demonstrated in numerous clinical studies; however, the results were controversial. In addition, no study was conducted in patients with obesity. As a result, this open-label, randomized controlled study aims to investigate efficacy and safety of mulberry leaves in combination with lifestyle intervention (diet control) on glycemic control in non-diabetic patients with obesity and patients with early-stage T2DM. Efficacy of the interventions will be assessed based on the changes in glycemic indexes, expression of proteins related to insulin resistance and T2DM, and lipid profiles. Meanwhile, safety will be measured by the changes in renal and hepatic enzymes and patient-self reports. The outcomes will be monitored at 4-week interval throughout 12 weeks of the study period.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Mulberry leaves powder, Diet control
- Keywords
- Mulberry leaves, Obesity, Type 2 Diabetes Mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry leaves powderDietary supplement
Dried powder of mulberry leaves crude extract containing 12 mg of DNJ will be packed in a sealed packet with light and moisture protection. Participants will be instructed to mix 1 packet of the powder with a half glass (approximately 120 mL) of plain water and ingest thrice daily before meals. Additionally, they will be informed to rinse the glass with more water and drink to ensure that all of the powder will be taken.
Diet controlBehavioural
Participants will be requested for diet control. They will be asked for attending the diet control program, maintaining diet pattern throughout the study period, and recording a 3-day food record. Individual counseling and assessment of compliance will be performed by licensed dietitians every 4 weeks. Diet control is principally based on carbohydrate counting.
| Study group | Role | What they receive |
|---|---|---|
| Mulberry leaves powder plus diet control | Experimental | Not described Receives: Dietary Supplement: Mulberry leaves powder; Behavioral: Diet control |
| Diet control alone | Other | Not described Receives: Behavioral: Diet control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of the 2-hour PPG (in mg/dL) during 75-g OGTT at week 12
Measured: 12 weeks
Effect on fasting plasma glucose (FPG) (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of FPG (in mg/dL) at week 4, 8, and 12
Measured: 12 weeks
Effect on glycated hemoglobin (A1C) (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of A1C (in %) at week 12
Measured: 12 weeks
Secondary outcomes (9)
Effect on total cholesterol (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of total cholesterol (in mg/dL) at week 12
Measured: 12 weeks
Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of HDL-C (in mg/dL) at week 12
Measured: 12 weeks
Effect on triglycerides (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of triglycerides (in mg/dL) at week 12
Measured: 12 weeks
Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of LDL-C (in mg/dL) at week 12
Measured: 12 weeks
Effect on insulin resistance index (efficacy)
To evaluate difference between the treatment group and the control group, and change from baseline of Homeostasis model assessment indexes of insulin resistance (HOMA-IR) at week 12
Measured: 12 weeks
Adverse effects on renal function (safety)
To evaluate difference between the treatment group and the control group, and change from baseline of serum creatinine (in mg/dL) at week 12
Measured: 12 weeks
Adverse effects on hepatic function 1 (safety)
To evaluate difference between the treatment group and the control group, and change from baseline of aspartate aminotransferase (AST) (in units/L) at week 12
Measured: 12 weeks
Adverse effects on hepatic function 2 (safety)
To evaluate difference between the treatment group and the control group, and change from baseline of alanine aminotransferase (ALT) (in units/L) at week 12
Measured: 12 weeks
Self-reported adverse events (safety)
Participants in the treatment group (those who were assigned to administer mulberry leaves) were asked to report adverse events caused by mulberry leaves administration (i.e. constipation, diarrhea, abdominal cramp, bloating, and hypoglycemia) to the researchers.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start26 May 2019
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691219
- Sponsor's protocol ID
- IRBRTA-Q038h/60
- Status last verified
- Dec 2020
- First submitted
- 6 Mar 2018
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04691219
- Acronym / sponsor ID
- IRBRTA-Q038h/60
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Mulberry leaves, Obesity, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 26 May 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 31 Dec 2020 (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.
A 12-week, open-label, randomized, controlled trial investigating effect of mulberry leaves plus lifestyle intervention on glycemic control compare with lifestyle intervention alone in patients with obesity and patients with type 2 diabetes (T2DM)
Detailed description
Diabetes remains a common leading cause of morbidity and mortality among population worldwide over decades. Obesity, a crucial risk factors for developing T2DM, commonly exists with insulin resistance and impaired beta-cell function. Early management in individuals at high risk of T2DM should be therefore considered for preventing or delaying the progression of diabetes and diabetic complications.
Since 1-deoxynojirimycin (DNJ), the major antihyperglycemic compound of mulberry leaves, inhibits alpha-glucosidase activities, ingestion of mulberry leaves results in the suppression of postprandial hyperglycemia. Long-term effects of mulberry leaves on glycemic profiles have been demonstrated in numerous clinical studies; however, the results were controversial. In addition, no study was conducted in patients with obesity. As a result, this open-label, randomized controlled study aims to investigate efficacy and safety of mulberry leaves in combination with lifestyle intervention (diet control) on glycemic control in non-diabetic patients with obesity and patients with early-stage T2DM. Efficacy of the interventions will be assessed based on the changes in glycemic indexes, expression of proteins related to insulin resistance and T2DM, and lipid profiles. Meanwhile, safety will be measured by the changes in renal and hepatic enzymes and patient-self reports. The outcomes will be monitored at 4-week interval throughout 12 weeks of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulberry leaves powder plus diet control | Experimental | Dietary Supplement: Mulberry leaves powder, Behavioral: Diet control |
| Diet control alone | Other | Behavioral: Diet control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women or men age 20-65 years
- Have 1 of 3 characteristics as follows;
- Well communicate in the Thai language
Key exclusion criteria (12 listed)
- Allergy to mulberry leaves products
- FPG ≥180 mg/dL
- A1c >8%
- AST and ALT >40 U/L
- Cr <0.6 or >1.2 mg/dL
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 leaves powderDried powder of mulberry leaves crude extract containing 12 mg of DNJ will be packed in a sealed packet with light and moisture protection. Participants will be instructed to mix 1 packet of the powder with a half glass (approximately 120 mL) of plain water and ingest thrice daily before meals. Additionally, they will be informed to rinse the glass with more water and drink to ensure that all of the powder will be taken. | Dietary supplement | Mulberry leaves powder plus diet control |
| Diet controlParticipants will be requested for diet control. They will be asked for attending the diet control program, maintaining diet pattern throughout the study period, and recording a 3-day food record. Individual counseling and assessment of compliance will be performed by licensed dietitians every 4 weeks. Diet control is principally based on carbohydrate counting. | Behavioural | Diet control alone, Mulberry leaves powder plus diet control |
Primary outcome
Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy)
Time frame: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of the 2-hour PPG (in mg/dL) during 75-g OGTT at week 12
Effect on fasting plasma glucose (FPG) (efficacy)
Time frame: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of FPG (in mg/dL) at week 4, 8, and 12
Effect on glycated hemoglobin (A1C) (efficacy)
Time frame: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of A1C (in %) at week 12
9 secondary outcomes
Effect on total cholesterol (efficacy)
Time frame: 12 weeks
Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)
Time frame: 12 weeks
Effect on triglycerides (efficacy)
Time frame: 12 weeks
Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)
Time frame: 12 weeks
Effect on insulin resistance index (efficacy)
Time frame: 12 weeks
Adverse effects on renal function (safety)
Time frame: 12 weeks
Adverse effects on hepatic function 1 (safety)
Time frame: 12 weeks
Adverse effects on hepatic function 2 (safety)
Time frame: 12 weeks
Self-reported adverse events (safety)
Time frame: 12 weeks
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 31 Dec 2020.
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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.
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 leaves powder in people with Obesity and Type 2 Diabetes Mellitus, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 12 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 31 Dec 2020. 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 Thailand. 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. 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?
Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 31 Dec 2020.