Effects of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
NCT04691219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-12-31
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
Interventions
- DIETARY_SUPPLEMENT
-
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.
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Chulalongkorn University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-26
- Primary Completion
- 2020-02-19
- Completion
- 2020-02-19
Countries
- Thailand
Study Locations
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