Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers

NCT ID: NCT06488326

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-02-25

Brief Summary

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.

Conditions

Health, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Mulberry leaf extract 6 mg capsule

Take one capsule of the sample one time.

Group Type: EXPERIMENTAL

Mulberry leaf extract 6 mg capsule

Intervention Type: DRUG

Take one capsule of the sample one time.

Mulberry leaf extract 12 mg capsule

Take one capsule of the sample one time.

Group Type: EXPERIMENTAL

Mulberry leaf extract 12 mg capsule

Intervention Type: DRUG

Take one capsule of the sample one time.

Mulberry leaf extract 18 mg capsule

Take one capsule of the sample one time.

Group Type: EXPERIMENTAL

Mulberry leaf extract 18 mg capsule

Intervention Type: DRUG

Take one capsule of the sample one time.

Placebo capsule

Take one capsule of the sample one time.

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DRUG

Take one capsule of the sample one time.

Interventions

Mulberry leaf extract 6 mg capsule

Take one capsule of the sample one time.

Intervention Type: DRUG

Mulberry leaf extract 12 mg capsule

Take one capsule of the sample one time.

Intervention Type: DRUG

Mulberry leaf extract 18 mg capsule

Take one capsule of the sample one time.

Intervention Type: DRUG

Placebo capsule

Take one capsule of the sample one time.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mae Fah Luang University

OTHER

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EC23188-20

Identifier Type: -

Identifier Source: org_study_id