Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
NCT ID: NCT04691219
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-05-26
2020-02-19
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mulberry leaves powder plus diet control
Mulberry leaves powder
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 control
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.
Diet control alone
Diet control
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.
Interventions
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Mulberry leaves powder
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 control
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Well communicate in the Thai language
Exclusion Criteria
2. FPG ≥180 mg/dL
3. A1c \>8%
4. AST and ALT \>40 U/L
5. Cr \<0.6 or \>1.2 mg/dL
6. BUN \>20 mg/dL
7. Existing or having history of gastrointestinal surgery or abnormal conditions affecting digestion and intestinal absorption
8. Existing or having history of hematological disorders, thyroid diseases, CVD, ischemic stroke, CKD, or other uncontrolled and life-threatening conditions
9. Presence of significant diabetic complications
10. 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
11. Taking unnecessary drugs, supplements, and herbs affecting lipid level within 1 month before study enrollment
12. Women during pregnancy or lactation
20 Years
65 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Pornanong Aramwit, Pharm.D., Ph.D
Professor
Locations
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Pornanong Aramwit
Bangkok, , Thailand
Countries
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Other Identifiers
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IRBRTA-Q038h/60
Identifier Type: -
Identifier Source: org_study_id