Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes

NCT04691219 | Completed DMC

• 1 other identifier: IRBRTA-Q038h/60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

Mulberry leaves; Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  12 weeks

Secondary Outcomes (9)

• Effect on total cholesterol (efficacy)

  12 weeks

• Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)

  12 weeks

• Effect on triglycerides (efficacy)

  12 weeks

• Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)

  12 weeks

• Effect on insulin resistance index (efficacy)

  12 weeks

Study Arms (2)

Mulberry leaves powder plus diet control

EXPERIMENTAL

Dietary Supplement: Mulberry leaves powder; Behavioral: Diet control

Diet control alone

OTHER

Behavioral: Diet control

Interventions

Mulberry leaves powder DIETARY_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.

Mulberry leaves powder plus diet control

Diet control BEHAVIORAL

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; Mulberry leaves powder plus diet control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Pornanong Aramwit

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: December 31, 2020
• Study Start: May 26, 2019
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

TH (1)