Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer

NCT07532135 | Recruiting Phase 1

• 1 other identifier: 0427/68
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.

Conditions

Healthy Volunteers; Non Diabetic Hyperglycemia

Keywords

Safety; mulberry; glucose; healthy

Outcome Measures

Primary Outcomes (7)

• Aspartate transaminase (AST) level

  Aspartate transaminase (AST) is in normal range.

  8 weeks

• Alanine aminotransferase (ALT) level

  Alanine aminotransferase (ALT) is in normal range.

  8 weeks

• Blood urea nitrogel level

  Blood urea nitrogen (BUN) is in normal range.

  8 weeks

• Creatinine level

  Creatinine is in normal range.

  8 weeks

• Complete blood counts

  Complete blood counts are in normal range.

  8 weeks

• Adverse events

  Adverse events are observed.

  8 weeks

• Alkaline phosphatase (ALP) level

  Alkaline phosphatase (ALP) is in normal range.

  8 weeks

Secondary Outcomes (1)

• Blood glucose level

  8 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

They took the sample 3 times/day for 8 weeks.

Other: Placebo

Mulberry leaf extract capsule (DNJ 12mg) group

EXPERIMENTAL

They took the sample 3 times/day for 8 weeks.

Combination Product: Mulberry Leaf Extract

Interventions

Mulberry Leaf Extract COMBINATION_PRODUCT

They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.

Mulberry leaf extract capsule (DNJ 12mg) group

Placebo OTHER

They took the sample 3 times/day for 8 weeks.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age more than 18 years
• No Diabetis mellitus disease and no taking diabetes medication
• Blood sugar level less than 126 mg/dl and HbA1C less than 6.5
• Can using Thai language
• Willing to participate in the study

You may not qualify if:

• Allergic to mulberry extract
• Take mulberry extract in 2 weeks before participate in this study
• Take medications that have effect on blood sugar level such as steroid in 2 weeks before participate in this study
• Have uncontrolled disease
• Have AST, ALT, ALP more than 3 times of normal value, or estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2)
• Pregnancy or lactation

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn

Bangkok, Thailand

RECRUITING

MeSH Terms

Interventions

Morus alba

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255; aramwit@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)