NCT06488326

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 28, 2024

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Mulberry leaf extract 6 mg capsule

EXPERIMENTAL

Take one capsule of the sample one time.

Drug: Mulberry leaf extract 6 mg capsule

Mulberry leaf extract 12 mg capsule

EXPERIMENTAL

Take one capsule of the sample one time.

Drug: Mulberry leaf extract 12 mg capsule

Mulberry leaf extract 18 mg capsule

EXPERIMENTAL

Take one capsule of the sample one time.

Drug: Mulberry leaf extract 18 mg capsule

Placebo capsule

PLACEBO COMPARATOR

Take one capsule of the sample one time.

Drug: Placebo capsule

Interventions

Take one capsule of the sample one time.

Mulberry leaf extract 6 mg capsule

Take one capsule of the sample one time.

Mulberry leaf extract 12 mg capsule

Take one capsule of the sample one time.

Mulberry leaf extract 18 mg capsule

Take one capsule of the sample one time.

Placebo capsule

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

February 25, 2025

Last Updated

July 5, 2024

Record last verified: 2024-06