Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers

Effect of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers

Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Then, they will take 1 capsule of the sample one time. After taking the sample for 30 minutes, they will take 50 g of sucrose in 250 ml of water in 5 minutes. Then, they will be tested blood glucose levels (taken from the fingertips) at 30, 60, 90, and 120 minutes.

Study Overview

• Status: Not yet recruiting
• Conditions: Health, Subjective
• Intervention / Treatment: Drug: Mulberry leaf extract 6 mg capsule; Drug: Mulberry leaf extract 12 mg capsule; Drug: Mulberry leaf extract 18 mg capsule; Drug: Placebo capsule

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-60 years
• No diabetes mellitus
• Have blood glucose less than 126 mg/dL
• Wiling to attend the study

Exclusion Criteria:

• Take steroids, psychiatric medicine, thiazide diuretic medicine, and beta blocker medicine within 2 weeks before starting of the study
• Take dietary supplement, herbal substance, and weight-loss medicine within 2 weeks before starting of the study
• Uncontrolled diseases
• History of gastrointestinal tract surgery
• Liver and Kidney diseases
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mulberry leaf extract 6 mg capsule; Take one capsule of the sample one time.	Drug: Mulberry leaf extract 6 mg capsule; Take one capsule of the sample one time.
Experimental: Mulberry leaf extract 12 mg capsule; Take one capsule of the sample one time.	Drug: Mulberry leaf extract 12 mg capsule; Take one capsule of the sample one time.
Experimental: Mulberry leaf extract 18 mg capsule; Take one capsule of the sample one time.	Drug: Mulberry leaf extract 18 mg capsule; Take one capsule of the sample one time.
Placebo Comparator: Placebo capsule; Take one capsule of the sample one time.	Drug: Placebo capsule; Take one capsule of the sample one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose	Volunteers will be measured the blood glucose using blood glucose meter and strip (accuchek) before and after taking the sample for 30, 60, 90, and 120 minutes.	120 minutes

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Mae Fah Luang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 25, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EC23188-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No