Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers

Chulalongkorn University

Status: Not yet enrolling

Conditions: Health, Subjective

Treatments: Drug: Mulberry leaf extract 12 mg capsule; Drug: Placebo capsule; Drug: Mulberry leaf extract 18 mg capsule; Drug: Mulberry leaf extract 6 mg capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06488326

EC23188-20

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 4 patient groups, including a placebo group

Mulberry leaf extract 6 mg capsule

Experimental group

Description:

Take one capsule of the sample one time.

Treatment:

Drug: Mulberry leaf extract 6 mg capsule

Mulberry leaf extract 12 mg capsule

Experimental group

Description:

Take one capsule of the sample one time.

Treatment:

Drug: Mulberry leaf extract 12 mg capsule

Mulberry leaf extract 18 mg capsule

Experimental group

Description:

Take one capsule of the sample one time.

Treatment:

Drug: Mulberry leaf extract 18 mg capsule

Placebo capsule

Placebo Comparator group

Description:

Take one capsule of the sample one time.

Treatment:

Drug: Placebo capsule