- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04691219
Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
Efficacy and Safety of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Pornanong Aramwit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mulberry leaves powder plus diet control
|
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.
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.
|
OTHER: Diet control alone
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
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
|
12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on total cholesterol (efficacy)
Time Frame: 12 weeks
|
To evaluate difference between the treatment group and the control group, and change from baseline of total cholesterol (in mg/dL) at week 12
|
12 weeks
|
Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)
Time Frame: 12 weeks
|
To evaluate difference between the treatment group and the control group, and change from baseline of HDL-C (in mg/dL) at week 12
|
12 weeks
|
Effect on triglycerides (efficacy)
Time Frame: 12 weeks
|
To evaluate difference between the treatment group and the control group, and change from baseline of triglycerides (in mg/dL) at week 12
|
12 weeks
|
Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)
Time Frame: 12 weeks
|
To evaluate difference between the treatment group and the control group, and change from baseline of LDL-C (in mg/dL) at week 12
|
12 weeks
|
Effect on insulin resistance index (efficacy)
Time Frame: 12 weeks
|
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
|
12 weeks
|
Adverse effects on renal function (safety)
Time Frame: 12 weeks
|
To evaluate difference between the treatment group and the control group, and change from baseline of serum creatinine (in mg/dL) at week 12
|
12 weeks
|
Adverse effects on hepatic function 1 (safety)
Time Frame: 12 weeks
|
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
|
12 weeks
|
Adverse effects on hepatic function 2 (safety)
Time Frame: 12 weeks
|
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
|
12 weeks
|
Self-reported adverse events (safety)
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBRTA-Q038h/60
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Mulberry leaves powder
-
University of Veterinary and Animal Sciences, Lahore...Recruiting
-
Universidade Nova de LisboaEuropean Commission; Fundação para a Ciência e a Tecnologia; Unidade Local de...Completed
-
Unilever R&DLambda Therapeutic Research Ltd.Completed
-
Sheba Medical CenterUnknownEdema | Surgical Wound | Surgery | Hematoma | Eye BruiseIsrael
-
Engelhard Arzneimittel GmbH & Co.KGCompleted
-
Société des Produits Nestlé (SPN)CompletedPost-prandial GlycemiaSwitzerland
-
Seoul St. Mary's HospitalRural Development Administration, KoreaCompletedOxidative StressKorea, Republic of
-
Taipei Medical UniversityNot yet recruitingVaccine Adverse Reaction | Side-Effect
-
University of Mississippi Medical CenterCompleted
-
Taipei Medical UniversityUnknownSystemic Inflammation | Interleukin | General Anxiety DisordersTaiwan